The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak X-omatic Ra Cassette.
Device ID | K890750 |
510k Number | K890750 |
Device Name: | KODAK X-OMATIC RA CASSETTE |
Classification | Cassette, Radiographic Film |
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 | IXA |
CFR Regulation Number | 892.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-13 |
Decision Date | 1989-03-01 |