The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Swabbable Valve Transfer Set.
| Device ID | K031808 |
| 510k Number | K031808 |
| Device Name: | MEDRAD SWABBABLE VALVE TRANSFER SET |
| Classification | Tubing, Fluid Delivery |
| 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 | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2003-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10616258005659 | K031808 | 000 |
| 40616258022053 | K031808 | 000 |
| 40616258024552 | K031808 | 000 |