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FDA Product Code

FDA Product Code GAN — Clearance Directory

Device Class
Class II
21 CFR Citation
878.4830

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K003015 SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD Surgical Specialties Corp 2000-12-15 Traditional PDF ↗
K964072 MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED ETHICON, Inc. 1996-12-18 Traditional PDF ↗
K960653 MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) ETHICON, Inc. 1996-03-28 Traditional PDF ↗
K951231 ORTHOPEDIC PACKS Sterile Concepts, Inc. 1995-12-01 Traditional PDF ↗
K920978 ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED ETHICON, Inc. 1994-02-15 Traditional PDF ↗
K900198 DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. American Cyanamid Co. 1990-07-05 Traditional PDF ↗
K895579 POLYSORB SYNTHETIC ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc 1990-07-05 Traditional PDF ↗

Product code GAN · Class II · General, Plastic Surgery. Data: openFDA.