FDA 510(k) Application Details - K062544

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K062544
Device Name	Instrument, Ultrasonic Surgical
Applicant	AROBELLA MEDICAL, LLC 11460 N. MERIDIAN STREET SUITE 150 CARMEL, IN 46032 US Other 510(k) Applications for this Company
Contact	Allison Scott Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LFL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2006
Decision Date	01/03/2007
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