The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Trophypan C With Orthoimaging/omsimaging Accessory.
Device ID | K040556 |
510k Number | K040556 |
Device Name: | TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Donald Ellis |
Correspondent | Donald Ellis EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-02 |
Decision Date | 2004-04-07 |
Summary: | summary |