K082307 is an FDA 510(k) clearance for the EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT. 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 September 11, 2008, 29 days after receiving the submission on August 13, 2008.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K082307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2008 |
| Decision Date | September 11, 2008 |
| Days to Decision | 29 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 |