FDA 510(k) Application Details - K981756

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K981756
Device Name	Mesh, Surgical, Polymeric
Applicant	SHELHIGH, INC. 67-71 EAST WILLOW ST. MILLBURN, NJ 07041 US Other 510(k) Applications for this Company
Contact	SHLOMO GABBAY Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/1998
Decision Date	08/05/1998
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