The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Manual Syringe Loader.
| Device ID | K031483 |
| 510k Number | K031483 |
| Device Name: | MEDRAD MANUAL SYRINGE LOADER |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Andrew P Zeltwanger |
| Correspondent | Andrew P Zeltwanger MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-12 |
| Decision Date | 2003-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258008813 | K031483 | 000 |