FDA 510(k) Application Details - K091363

Device Classification Name Filter, Bacterial, Breathing-Circuit

  More FDA Info for this Device
510(K) Number K091363
Device Name Filter, Bacterial, Breathing-Circuit
Applicant AG INDUSTRIES
1705. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN, TX 78746 US
Other 510(k) Applications for this Company
Contact IAN GORDON
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 05/08/2009
Decision Date 02/04/2010
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact