The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Disposable Syringes.
| Device ID | K964642 |
| 510k Number | K964642 |
| Device Name: | MEDRAD DISPOSABLE SYRINGES |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt 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 | 1996-11-19 |
| Decision Date | 1997-04-29 |
| Summary: | summary |