K090905 is an FDA 510(k) clearance for the ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on April 27, 2009, 26 days after receiving the submission on April 1, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K090905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2009 |
| Decision Date | April 27, 2009 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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 |