FDA 510(k) Application Details - K994199

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K994199
Device Name	Drape, Surgical
Applicant	CUSTOM MEDICAL PRODUCTS, INC. 1 HOLIDAY INN DR. BUILDING E ASHEVILLE, NC 28806 US Other 510(k) Applications for this Company
Contact	STEVE WOODY Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/1999
Decision Date	06/09/2000
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