K093145 is an FDA 510(k) clearance for the SPECTRA SERIES BREAST PUMP. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Uzinmedicare Co. (Yongin, KR). The FDA issued a Cleared decision on August 13, 2010, 312 days after receiving the submission on October 5, 2009.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K093145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2009 |
| Decision Date | August 13, 2010 |
| Days to Decision | 312 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 |