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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 K951352
Device Name DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE
Applicant
Davis & Geck, Inc.
One Casper St.
Danbury,  CT  06810
Applicant Contact S. J TAMSETT
Correspondent
Davis & Geck, Inc.
One Casper St.
Danbury,  CT  06810
Correspondent Contact S. J TAMSETT
Regulation Number878.4493
Classification Product Code
GAM  
Date Received03/24/1995
Decision Date 06/05/1995
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
Predetermined Change
Control Plan Authorized		 No
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