FDA 510(k) Application Details - K013686

Device Classification Name Cassette, Radiographic Film

  More FDA Info for this Device
510(K) Number K013686
Device Name Cassette, Radiographic Film
Applicant EASTMAN KODAK COMPANY
1669 LAKE AVE.
ROCHESTER, NY 14652 US
Other 510(k) Applications for this Company
Contact JUDITH A WALLACE
Other 510(k) Applications for this Contact
Regulation Number 892.1850

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

  More FDA Info for this Product Code
Date Received 11/07/2001
Decision Date 12/07/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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