FDA 510(k) Application Details - K080532

Device Classification Name	More FDA Info for this Device
510(K) Number	K080532
Device Name	BENACEL, MODELS C-001, C-002 AND C-005
Applicant	UNICARE BIOMEDICAL, INC. 22971-B TRITON WAY LAGUNA HILLS, CA 92653 US Other 510(k) Applications for this Company
Contact	STAN YANG Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2008
Decision Date	11/12/2008
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