The following data is part of a premarket notification filed by Medsource International, Llc. with the FDA for Medsource Iv Adminstration Set.
| Device ID | K120424 |
| 510k Number | K120424 |
| Device Name: | MEDSOURCE IV ADMINSTRATION SET |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DRIVE Mound, MN 55318 |
| Contact | Jennifer Ness |
| Correspondent | Jennifer Ness MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DRIVE Mound, MN 55318 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-13 |
| Decision Date | 2012-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840155412323 | K120424 | 000 |
| 00840155412484 | K120424 | 000 |
| 00840155412453 | K120424 | 000 |