Cdrh 510 k database search
Web510(k) Premarket Notification (Traditional) for ECHELON LINEARTM Cutter 510(k) Summary I. SUBMITTER Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 Contact: Alicia Butler Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. Phone: 513-337-1633 Email: [email protected] Date Prepared: December 15, 2024 II. WebMar 20, 2024 · While the CDRH Portal features online progress tracking for 510 (k) submissions, the FDA also formally notifies you of your 510 (k) submission's status by …
Cdrh 510 k database search
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WebJan 5, 2024 · This page lists all medical devices cleared through the CDRH Premarket Notification process [510(K)] in 2024. January 2024 510(K) Clearances; February 2024 … WebJul 27, 2009 · FDA > CDRH > CFR Title 21 Database Search Sec. 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). …
WebFDA > CDRH > Device Registra Database Search. words connected by and (e.g., electromechanical and infusion). To Search by Establishment, Registration Number or … WebBioFire® Global Fever Special Pathogens Panel 510(k) Summary BioFire Defense, LLC IV. Device Description The BioFire® Global Fever Special Pathogens Panel is a multiplexed nucleic acid-based test designed to be used with BioFire ®®FilmArray Systems (BioFire FilmArray® 2.0 or BioFire® FilmArray® Torch). The BioFire Global Fever Special …
WebBioFire® Global Fever Special Pathogens Panel 510(k) Summary BioFire Defense, LLC IV. Device Description The BioFire® Global Fever Special Pathogens Panel is a multiplexed … WebA search query will produce information from the database in the following format: You can search the releasable 510(k) database by Panel, 510(k) number, Product code or … A 510(K) is a premarket submission made to FDA to demonstrate that the device to … Listings of CDRH Substantially Equivalent 510(k)s are normally available about the …
Web510(k) Summary K223609 RevCore™ Thrombectomy Catheter The following “510(k) Summary” of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. 1.0 Submitter Information [ 21 CFR 807.92(a) (1)] Submitter: Inari Medical, Inc. Address: 6001 Oak Canyon, Suite 100 Irvine, CA 92618 USA
Web510(k) Premarket Notification (Traditional) for ECHELON LINEARTM Cutter 510(k) Summary I. SUBMITTER Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, … rick lagina of oak islandWeb510(k)s; De Novo; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device … red snapper columbia scWeb510(K) Number. Decision Date. single size tendon spacer: MEDIST INTERNATIONAL k000019: 03/29/2000: cortek mini laparoscope: CORTEK ENDOSCOPY, INC. k000199: … red snapper fishing rig set upWebThese sets were previously cleared under 510(k) premarket notification K932512 on Feb 22, 1994. The devices covered in this submission are substantially equivalent to the … rick laing i left my heart in rhodesiarick lahmann piano selectionsWebGalaxy System 510(k) Notification Page 1 of 4 510(k) Summary This summary of 510(k) for information regarding substantial equivalency is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. 510(k) Number: K223144 Applicant Information: Date Prepared: Manufacturer: Contact Person: Mobile Number: Fax: Device ... rick landis attorney kinston ncWeb510(K) Summary-K220673 1/5 510(K) Summary - K220673 This 510(K) Summary information is being submitted in accordance with 21 CFR 807.92. I. SUBMITTER: Qingdao Bright Moon Biomedical Materials Co., Ltd. No. 788, Bright Moon Road, Huangdao District, Qingdao, Shandong,China Contact Person: Deng yunlong rick laguna worth