The following data is part of a premarket notification filed by Agfa Corporation with the FDA for Drystar Model 5500.
| Device ID | K052251 |
| 510k Number | K052251 |
| Device Name: | DRYSTAR MODEL 5500 |
| Classification | Camera, Multi Format, Radiological |
| Applicant | AGFA CORPORATION 10 SOUTH ACADEMY STREET Greenville, SC 29602 -9048 |
| Contact | Jeff Jedlicka |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-18 |
| Decision Date | 2005-08-31 |
| Summary: | summary |