FDA 510(k) Application Details - K010709

Device Classification Name	Sizer, Mammary, Breast Implant Volume   More FDA Info for this Device
510(K) Number	K010709
Device Name	Sizer, Mammary, Breast Implant Volume
Applicant	MENTOR CORP. 201 MENTOR DR. SANTA BARBARA, CA 93111 US Other 510(k) Applications for this Company
Contact	DONNA CRAWFORD 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	03/09/2001
Decision Date	04/23/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review