FDA 510(k) Application Details - K993785

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K993785
Device Name	Staple, Implantable
Applicant	INRAD 3956 44TH ST., S.E. KENTWOOD, MI 49512 US Other 510(k) Applications for this Company
Contact	JOSEPH M MAZUREK Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/1999
Decision Date	02/04/2000
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