The following data is part of a premarket notification filed by West Pharmaceutical Services, Inc. with the FDA for Clip 'n'ject Reconstitution System (clip 'n'ject.
| Device ID | K041691 |
| 510k Number | K041691 |
| Device Name: | CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | WEST PHARMACEUTICAL SERVICES, INC. 101 GORDON DR. Lionville, PA 19341 |
| Contact | David Weiser |
| Correspondent | David Weiser WEST PHARMACEUTICAL SERVICES, INC. 101 GORDON DR. Lionville, PA 19341 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-22 |
| Decision Date | 2004-08-05 |
| Summary: | summary |