FDA 510(k) Application Details - K954490

Device Classification Name Filter, Bacterial, Breathing-Circuit

  More FDA Info for this Device
510(K) Number K954490
Device Name Filter, Bacterial, Breathing-Circuit
Applicant MERCURY MEDICAL
11300-A 49TH ST. NORTH
CLEARWATER, FL 34622-4800 US
Other 510(k) Applications for this Company
Contact KATHY L HANN
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 09/27/1995
Decision Date 10/03/1996
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

FDA Source Information for K954490


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