FDA 510(k) Application Details - K043234

Device Classification Name	Cover, Barrier, Protective   More FDA Info for this Device
510(K) Number	K043234
Device Name	Cover, Barrier, Protective
Applicant	WRAPPED IN COMFORT 15760 VIA SONATA SAN LORENZO, CA 94580 US Other 510(k) Applications for this Company
Contact	JANE GETSLA Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	MMP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2004
Decision Date	05/25/2005
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