FDA 510(k) Application Details - K974068

Device Classification Name	Respirator,Surgical   More FDA Info for this Device
510(K) Number	K974068
Device Name	Respirator,Surgical
Applicant	TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. FORT WORTH, TX 76180 US Other 510(k) Applications for this Company
Contact	RUTH JONES Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	MSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/1997
Decision Date	12/22/1997
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