FDA 510(k) Application Details - K030908

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K030908
Device Name	Drape, Surgical
Applicant	DEROYAL 200 DEBUSK LN. POWELL, TN 37849 US Other 510(k) Applications for this Company
Contact	AUDREY DANIELS 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	03/24/2003
Decision Date	08/11/2003
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