K112856 is an FDA 510(k) clearance for the LUCINA-MELODI. This device is classified as a Pump, Breast, Powered (Class II — Special Controls, product code HGX).
Submitted by Genadyne Biotechnologies, Inc. (Hicksville, US). The FDA issued a Cleared decision on May 10, 2012, 223 days after receiving the submission on September 30, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K112856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2011 |
| Decision Date | May 10, 2012 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGX — Pump, Breast, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5160 |