FDA 510(k) Application Details - K971128

Device Classification Name Table, Radiographic, Tilting

  More FDA Info for this Device
510(K) Number K971128
Device Name Table, Radiographic, Tilting
Applicant JAMIESON FILM CO.
10425 OLYMPIC DR.
DALLAS, TX 75220-4427 US
Other 510(k) Applications for this Company
Contact GARY W FULLER
Other 510(k) Applications for this Contact
Regulation Number 892.1980

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

  More FDA Info for this Product Code
Date Received 03/27/1997
Decision Date 04/28/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
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