The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodatrol Liquid Control Levels I & Ii.
| Device ID | K903189 |
| 510k Number | K903189 |
| Device Name: | KODATROL LIQUID CONTROL LEVELS I & II |
| Classification | Drug Mixture Control Materials |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Contact | Norman H Geil |
| Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-19 |
| Decision Date | 1990-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750008957 | K903189 | 000 |
| 10758750004959 | K903189 | 000 |