The following data is part of a premarket notification filed by Uzinmedicare Co. with the FDA for Spectra Q.
| Device ID | K191109 |
| 510k Number | K191109 |
| Device Name: | Spectra Q |
| Classification | Pump, Breast, Powered |
| Applicant | Uzinmedicare Co. Rm 105, Joongang Induspia V, Sagimakgolo 137, Jungwon-gu, Seongnam-Si, Gyeonggi-do, 13202, South Korea Seongnam-si, KR 13202 |
| Contact | Jisun Lee |
| Correspondent | Dogyun Im GMS Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu, Seoul, Republic Of Korea Seoul-si, KR 03909 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-26 |
| Decision Date | 2020-01-22 |