K191208 is an FDA 510(k) clearance for the Spectra Cashmere. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Uzinmedicare Co. (Hwaseong-Si, KR). The FDA issued a Cleared decision on October 11, 2019, 158 days after receiving the submission on May 6, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K191208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2019 |
| Decision Date | October 11, 2019 |
| Days to Decision | 158 days |
| Submission Type | Special |
| 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 |