The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Insight Twin-load Insert.
Device ID | K942909 |
510k Number | K942909 |
Device Name: | KODAK INSIGHT TWIN-LOAD INSERT |
Classification | Screen, Intensifying, 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 | EAM |
CFR Regulation Number | 892.1960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-21 |
Decision Date | 1994-07-29 |