FDA 510(k) Application Details - K063746

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K063746
Device Name	Staple, Implantable
Applicant	POWER MEDICAL INTERVENTIONS, INC. 2021 CABOT BLVD. LANGHORNE, PA 19047 US Other 510(k) Applications for this Company
Contact	BARBARA WHITMAN 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	12/18/2006
Decision Date	01/12/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review