FDA 510(k) Application Details - K970102

Device Classification Name	Filter, Bacterial, Breathing-Circuit   More FDA Info for this Device
510(K) Number	K970102
Device Name	Filter, Bacterial, Breathing-Circuit
Applicant	PROMEDIC, INC. 6329 WEST WATERVIEW CT. MCCORDSVILLE, IN 46055-9501 US Other 510(k) Applications for this Company
Contact	PAUL E DRYDEN 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	01/13/1997
Decision Date	06/24/1997
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