The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Dryview 8900 Laser Imager Mammography Accessory.
| Device ID | K033821 |
| 510k Number | K033821 |
| Device Name: | KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY |
| Classification | Camera, Multi Format, Radiological |
| Applicant | EASTMAN KODAK COMPANY 1 IMATION WAY Oakdale, MN 55128 -3414 |
| Contact | Stephen Slavens |
| Correspondent | Stephen Slavens EASTMAN KODAK COMPANY 1 IMATION WAY Oakdale, MN 55128 -3414 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-09 |
| Decision Date | 2004-02-20 |
| Summary: | summary |