FDA 510(k) Application Details - K990253

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K990253
Device Name	Drape, Surgical
Applicant	AMBA MEDICAL LTD. BONVILLE ROAD BRISLINGTON BRISTOL BS4 5QH BS4 5QH GB Other 510(k) Applications for this Company
Contact	MIKE CAUDWELL 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	01/27/1999
Decision Date	09/24/1999
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