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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 K963175
Device Name GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
Applicant
Glycar, Inc.
4537 Belclaire Ave.
Dallas,  TX  75205
Applicant Contact DIRK FRATER
Correspondent
Glycar, Inc.
4537 Belclaire Ave.
Dallas,  TX  75205
Correspondent Contact DIRK FRATER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received08/14/1996
Decision Date 09/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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