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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K896946
Device Name COATED NOVAFIL, POLYBUTESTER, MESH
Applicant
AMERICAN CYANAMID CO.
ONE CASPER ST.
DANBURY,  CT  06810
Applicant Contact B. I PARZUCHOWSKI
Correspondent
AMERICAN CYANAMID CO.
ONE CASPER ST.
DANBURY,  CT  06810
Correspondent Contact B. I PARZUCHOWSKI
Regulation Number878.3300
Classification Product Code
FTM  
Date Received12/13/1989
Decision Date 05/07/1990
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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