FDA 510(k) Application Details - K052668

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K052668
Device Name	Drape, Surgical
Applicant	OR SPECIFIC, INC. 4651 36TH ST. #500 ORLANDO, FL 32811 US Other 510(k) Applications for this Company
Contact	Daniel Becker 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	09/27/2005
Decision Date	07/24/2006
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