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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K945701
Device Name SURGILENE(R) SUTURES
Applicant
Davis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury,  CT  06810
Applicant Contact STEVE TAMSETT
Correspondent
Davis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury,  CT  06810
Correspondent Contact STEVE TAMSETT
Regulation Number878.5010
Classification Product Code
GAW  
Date Received11/09/1994
Decision Date 01/24/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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