K041691 is an FDA 510(k) clearance for the CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by West Pharmaceutical Services, Inc. (Lionville, US). The FDA issued a Cleared decision on August 5, 2004, 44 days after receiving the submission on June 22, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K041691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2004 |
| Decision Date | August 05, 2004 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |