FDA 510(k) Application Details - K053495

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K053495
Device Name	Drape, Surgical
Applicant	ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. MARIETTA, GA 30066 US Other 510(k) Applications for this Company
Contact	WILLIAM SLEVIN 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	12/15/2005
Decision Date	03/16/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review