FDA 510(k) Application Details - K960853

Device Classification Name Bur, Ear, Nose And Throat

  More FDA Info for this Device
510(K) Number K960853
Device Name Bur, Ear, Nose And Throat
Applicant XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216-0980 US
Other 510(k) Applications for this Company
Contact DAVID M TIMLIN
Other 510(k) Applications for this Contact
Regulation Number 874.4140

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

  More FDA Info for this Product Code
Date Received 03/01/1996
Decision Date 04/03/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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