FDA 510(k) Application Details - K955513

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K955513
Device Name	Mask, Surgical
Applicant	UNITED MEDICAL ENT., INC. 5003 WRIGHTSBORO RD. GROVETOWN, GA 30813 US Other 510(k) Applications for this Company
Contact	HERSCHEL PITTS Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/1995
Decision Date	04/22/1996
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