FDA 510(k) Application Details - K021546

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K021546
Device Name	Mask, Surgical
Applicant	CREATIVE CONTRACT (M) SDN BHD 8220 CHARLES PAGE BLVD. SAND SPRINGS, OK 74063 US Other 510(k) Applications for this Company
Contact	MARK REIBER Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2002
Decision Date	03/05/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review