FDA 510(k) Application Details - K964467

Device Classification Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene   More FDA Info for this Device
510(K) Number	K964467
Device Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant	SHELHIGH, INC. 67 E. WILLOW ST. MILLBURN, NJ 07041 US Other 510(k) Applications for this Company
Contact	SHLOMO GABBAY, M.D. Other 510(k) Applications for this Contact
Regulation Number	870.3470   More FDA Info for this Regulation Number
Classification Product Code	DXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/1996
Decision Date	09/23/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review