The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Transfer Set.
| Device ID | K022431 |
| 510k Number | K022431 |
| Device Name: | MEDRAD TRANSFER SET |
| Classification | Tubing, Fluid Delivery |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Frank W Pelc Iii |
| Correspondent | Frank W Pelc Iii MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-25 |
| Decision Date | 2002-09-05 |
| Summary: | summary |