The following data is part of a premarket notification filed by Medsource International, Llc. with the FDA for Medsource Iv Administration Set 72 Medsource Iv Administration Set, Needleless Male Adapter, Medsource Iv Extension Set.
| Device ID | K140402 |
| 510k Number | K140402 |
| Device Name: | MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DR. Mound, MN 55364 |
| Contact | Jennifer Ness |
| Correspondent | Jennifer Ness MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DR. Mound, MN 55364 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-04-03 |