The following data is part of a premarket notification filed by Uzinmedicare Company with the FDA for Spectra 9plus.
| Device ID | K162415 |
| 510k Number | K162415 |
| Device Name: | Spectra 9Plus |
| Classification | Pump, Breast, Powered |
| Applicant | Uzinmedicare Company Room 105, Joongang Induspia V, Sagimakgolo 137 Jungwon-gu, Seoungnam-Si Seoul, KR 13202 |
| Contact | Nathan Ahn |
| Correspondent | Jeffrey K. Shapiro Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, DC 20005 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-29 |
| Decision Date | 2017-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28809108011354 | K162415 | 000 |
| 08809108015754 | K162415 | 000 |
| 08809108016485 | K162415 | 000 |
| 28809108016441 | K162415 | 000 |