K092770 is an FDA 510(k) clearance for the SIMPLYGO HANDS FREE BREAST PUMP. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Evenflo Company, Inc. (Miamisburg, US). The FDA issued a Cleared decision on October 9, 2009, 30 days after receiving the submission on September 9, 2009.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K092770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2009 |
| Decision Date | October 09, 2009 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGX — Pump, Breast, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5160 |