FDA 510(k) Application Details - K972109

Device Classification Name	Expander, Surgical, Skin Graft   More FDA Info for this Device
510(K) Number	K972109
Device Name	Expander, Surgical, Skin Graft
Applicant	GENERAL SURGICAL INNOVATIONS 10460 BUBB RD. CUPERTINO, CA 95014 US Other 510(k) Applications for this Company
Contact	CATHLEEN MANTOR Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/1997
Decision Date	11/14/1997
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