510(k) K970059

KODAK MINILOADER(2000) by Eastman Kodak Company — Product Code IXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1997
Date Received
January 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type