FDA 510(k) Application Details - K982239

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K982239
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	ARC MEDICAL, INC. 322 PATTERSON AVE. SCOTTDALE, GA 30079 US Other 510(k) Applications for this Company
Contact	HAROLD B NORRIS Other 510(k) Applications for this Contact
Regulation Number	868.5260   More FDA Info for this Regulation Number
Classification Product Code	CAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/1998
Decision Date	08/14/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review