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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.
Original Applicant
SHELHIGH, INC.
67 e. willow st.
millburn,  NJ  07041
Original Contact shlomo gabbay
Regulation Number878.3300
Classification Product Code
FTM  
Date Received05/05/1999
Decision Date 07/14/1999
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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