FDA 510(k) Application Details - K041331

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K041331
Device Name	Staple, Implantable
Applicant	BIOPSY SCIENCES, LLC 5582 CHALON RD. YORBA LINDA, CA 92886 US Other 510(k) Applications for this Company
Contact	SHARON ROCKWELL 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	05/19/2004
Decision Date	06/15/2004
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