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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 K991567
Device Name SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
Applicant
SHELHIGH, INC.
67 E. WILLOW ST.
MILLBURN,  NJ  07041
Applicant Contact SHLOMO GABBAY
Correspondent
SHELHIGH, INC.
67 E. WILLOW ST.
MILLBURN,  NJ  07041
Correspondent Contact SHLOMO GABBAY
Regulation Number878.3300
Classification Product Code
FTM  
Date Received05/05/1999
Decision Date 07/14/1999
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
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