The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Drystar 5300 Medical Image Printer, Model 5300.
| Device ID | K032635 |
| 510k Number | K032635 |
| Device Name: | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 |
| Classification | Camera, Multi Format, Radiological |
| Applicant | AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Jeff Jedlicka |
| Correspondent | Jeff Jedlicka AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-26 |
| Decision Date | 2003-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904161470 | K032635 | 000 |
| 05414904015681 | K032635 | 000 |