The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Directview Cr Cassette/gp/15 X 30 Cm, Catalog# 8418253.
| Device ID | K040378 |
| 510k Number | K040378 |
| Device Name: | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 |
| Classification | Cassette, Radiographic Film |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Contact | Susan Pate |
| Correspondent | Susan Pate EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978933884 | K040378 | 000 |
| 60889971603241 | K040378 | 000 |
| 60889971600004 | K040378 | 000 |
| 60889971433701 | K040378 | 000 |
| 60889971157539 | K040378 | 000 |
| 60889971089410 | K040378 | 000 |
| 60889971031761 | K040378 | 000 |
| 60889978413515 | K040378 | 000 |
| 60889971269676 | K040378 | 000 |
| 60889971640987 | K040378 | 000 |
| 60889971827296 | K040378 | 000 |
| 60889978754144 | K040378 | 000 |
| 60889978619108 | K040378 | 000 |
| 60889978448760 | K040378 | 000 |
| 60889978445943 | K040378 | 000 |
| 60889978294459 | K040378 | 000 |
| 60889978104147 | K040378 | 000 |
| 60889971933980 | K040378 | 000 |
| 60889971831989 | K040378 | 000 |
| 60889971044617 | K040378 | 000 |