FDA 510(k) Application Details - K030653

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K030653
Device Name	Staple, Implantable
Applicant	POWER MEDICAL INTERVENTIONS, INC. 110 UNION SQUARE DR. NEW HOPE, PA 18938-1364 US Other 510(k) Applications for this Company
Contact	BABARA J 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	03/03/2003
Decision Date	03/31/2003
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