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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K930588
Device Name DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID
Applicant
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Applicant Contact JOHN SCHAEFER
Correspondent
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Correspondent Contact JOHN SCHAEFER
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
GAL  
Date Received02/04/1993
Decision Date 01/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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