The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Automixer Iii Integrated, Kodak Automixer Iii 180 Lp.
Device ID | K940386 |
510k Number | K940386 |
Device Name: | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP |
Classification | Device, Spot-film |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Normal Geil |
Correspondent | Normal Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | IXL |
CFR Regulation Number | 892.1670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-26 |
Decision Date | 1994-08-17 |