FDA 510(k) Application Details - K091636

Device Classification Name	Wax,Bone   More FDA Info for this Device
510(K) Number	K091636
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	06/04/2009
Decision Date	06/22/2009
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