FDA 510(k) Application Details - K991567

Device Classification Name Mesh, Surgical

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510(K) Number K991567
Device Name Mesh, Surgical
Applicant SHELHIGH, INC.
67 E. WILLOW ST.
MILLBURN, NJ 07041 US
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Contact SHLOMO GABBAY
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 05/05/1999
Decision Date 07/14/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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