The following data is part of a premarket notification filed by Uzinmedicare Co. with the FDA for Spectra S1plus And Spectra S2 Plus.
| Device ID | K150476 |
| 510k Number | K150476 |
| Device Name: | Spectra S1Plus And Spectra S2 Plus |
| Classification | Pump, Breast, Powered |
| Applicant | UZINMEDICARE CO. Rm 105, Joongang Induspia V, Sagimakgolo 137 Jungwon-gu, KR 462-807 |
| Contact | Ho Jun Kang |
| Correspondent | Charlene Cho Onbix Corporation 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 | 2015-02-24 |
| Decision Date | 2016-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28809108011309 | K150476 | 000 |
| 08809108011091 | K150476 | 000 |