FDA 510(k) Application Details - K994262

Device Classification Name Cannula, Sinus

  More FDA Info for this Device
510(K) Number K994262
Device Name Cannula, Sinus
Applicant XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216-0980 US
Other 510(k) Applications for this Company
Contact MARTIN D SARGENT
Other 510(k) Applications for this Contact
Regulation Number 878.4800

  More FDA Info for this Regulation Number
Classification Product Code KAM
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/17/1999
Decision Date 02/08/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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