FDA 510(k) Application Details - K980895

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K980895
Device Name	Instrument, Ultrasonic Surgical
Applicant	CALIFORNIA INSTITUTE OF TISSUE ENG. & INSTRUMENTI 205 SOUTH WEST ST., SUITE A VISALIA, CA 93291 US Other 510(k) Applications for this Company
Contact	JEFF WHEATON 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	03/09/1998
Decision Date	11/06/1998
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