FDA 510(k) Application Details - K082491

Device Classification Name	Wax,Bone   More FDA Info for this Device
510(K) Number	K082491
Device Name	Wax,Bone
Applicant	CEREMED, INC. 3643 LENAWEE AVE. LOS ANGELES, CA 90016 US Other 510(k) Applications for this Company
Contact	TADEUSZ WELLISZ Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2008
Decision Date	09/24/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review