The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Contrast Holder.
| Device ID | K964782 |
| 510k Number | K964782 |
| Device Name: | MEDRAD CONTRAST HOLDER |
| Classification | Stand, Infusion |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Sandra A Pavlovic |
| Correspondent | Sandra A Pavlovic MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | FOX |
| CFR Regulation Number | 880.6990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-02-25 |
| Summary: | summary |