FDA 510(k) Application Details - K973476

Device Classification Name Unit, X-Ray, Extraoral With Timer

  More FDA Info for this Device
510(K) Number K973476
Device Name Unit, X-Ray, Extraoral With Timer
Applicant EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER, NY 14650-1131 US
Other 510(k) Applications for this Company
Contact JUDITH A WALLACE
Other 510(k) Applications for this Contact
Regulation Number 872.1800

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

  More FDA Info for this Product Code
Date Received 09/15/1997
Decision Date 11/10/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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