FDA 510(k) Application Details - K053464

Device Classification Name Apparatus, Exhaust, Surgical

  More FDA Info for this Device
510(K) Number K053464
Device Name Apparatus, Exhaust, Surgical
Applicant CONMED INTEGRATED SYSTEMS, CANADA, ULC
11311 CONCEPT BLVD
LARGO, FL 33773-4908 US
Other 510(k) Applications for this Company
Contact MICHAEL T TAGGART
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 12/13/2005
Decision Date 06/06/2006
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



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