K052999 is an FDA 510(k) clearance for the SEMPERFLO INFUSION SYSTEM. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by Ethicon, Inc. (Sommerville, US). The FDA issued a Cleared decision on March 22, 2006, 148 days after receiving the submission on October 25, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K052999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2005 |
| Decision Date | March 22, 2006 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEB — Pump, Infusion, Elastomeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |