The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan Sp Cassette.
Device ID | K925997 |
510k Number | K925997 |
Device Name: | KODAK EKTASCAN SP CASSETTE |
Classification | Grid, 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 | IXJ |
CFR Regulation Number | 892.1910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-27 |
Decision Date | 1992-12-17 |