FDA 510(k) Application Details - K971744

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K971744
Device Name	Mask, Surgical
Applicant	BERKLEY MEDICAL RESOURCES, INC. 31 INNSBROOK RD. ASHVILLE, NC 28804 US Other 510(k) Applications for this Company
Contact	FRANK R DASTOLI 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	05/12/1997
Decision Date	07/28/1997
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