The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak X-omatic Identification Camera, Model 4 & 4l.
Device ID | K926404 |
510k Number | K926404 |
Device Name: | KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L |
Classification | System, X-ray, Film Marking, Radiographic |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Norman H Geil |
Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | JAC |
CFR Regulation Number | 892.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-21 |
Decision Date | 1993-03-04 |