FDA 510(k) Application Details - K970352

Device Classification Name	Apparatus, Exhaust, Surgical   More FDA Info for this Device
510(K) Number	K970352
Device Name	Apparatus, Exhaust, Surgical
Applicant	ISOMEDIX OPERATIONS INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY MCNAMARA-CULLINANE, RAC Other 510(k) Applications for this Contact
Regulation Number	878.5070   More FDA Info for this Regulation Number
Classification Product Code	FYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/1997
Decision Date	11/04/1997
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