FDA 510(k) Application Details - K961356

Device Classification Name	Sizer, Mammary, Breast Implant Volume   More FDA Info for this Device
510(K) Number	K961356
Device Name	Sizer, Mammary, Breast Implant Volume
Applicant	GENERAL SURGICAL INNOVATIONS 3172A PORTER DR. PALO ALTO, CA 94304 US Other 510(k) Applications for this Company
Contact	THERESA M NARAROFF Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/1996
Decision Date	09/23/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review