FDA 510(k) Application Details - K971130

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K971130
Device Name	Mask, Surgical
Applicant	CARL PARKER ASSOCIATES, INC. 8309 BRYANT DR. BETHESDA, MD 20817 US Other 510(k) Applications for this Company
Contact	NEAL DUNNING 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	03/27/1997
Decision Date	06/27/1997
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