FDA 510(k) Application Details - K955749

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K955749
Device Name	Drape, Surgical
Applicant	FLYNT AMTEX, INC. 673 GILMER ST. BURLINGTON, NC 27217 US Other 510(k) Applications for this Company
Contact	JOHN A KRANASKAS 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	12/19/1995
Decision Date	11/22/1996
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