K102600 is an FDA 510(k) clearance for the SIMPLYGO 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 December 22, 2010, 103 days after receiving the submission on September 10, 2010.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K102600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2010 |
| Decision Date | December 22, 2010 |
| Days to Decision | 103 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 |