FDA 510(k) Application Details - K004005

Device Classification Name	More FDA Info for this Device
510(K) Number	K004005
Device Name	MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
Applicant	MENTOR CORP. 201 MENTOR DR. SANTA BARBARA, CA 93111 US Other 510(k) Applications for this Company
Contact	DONNA A CRAWFORD Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2000
Decision Date	10/12/2001
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