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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, polymeric
510(k) Number K954665
Device Name GLYCAR STAPLE STRIPS
Applicant
GLYCAR, INC.
4537 BELCLAIRE AVE.
DALLAS,  TX  75205
Applicant Contact DIRK A FRATER
Correspondent
GLYCAR, INC.
4537 BELCLAIRE AVE.
DALLAS,  TX  75205
Correspondent Contact DIRK A FRATER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/10/1995
Decision Date 02/14/1996
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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