FDA 510(k) Application Details - K094016

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K094016
Device Name	Drape, Surgical
Applicant	HINSON AND HALE MEDICAL TECHNOLOGIES, INC 7809 ADELAIDE DRIVE AUSTIN, TX 78739 US Other 510(k) Applications for this Company
Contact	JEFFREY O STULL 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	12/29/2009
Decision Date	11/19/2010
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