The following data is part of a premarket notification filed by Uzinmedicare Co. with the FDA for Spectra Series Breast Pump.
| Device ID | K093145 |
| 510k Number | K093145 |
| Device Name: | SPECTRA SERIES BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | UZINMEDICARE CO. 503 -2 CHANG-RI, NAMSA -MYEON Yongin, KR 449-885 |
| Contact | Yong J Choi |
| Correspondent | Yong J Choi UZINMEDICARE CO. 503 -2 CHANG-RI, NAMSA -MYEON Yongin, KR 449-885 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-05 |
| Decision Date | 2010-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851690007028 | K093145 | 000 |
| 00851690007004 | K093145 | 000 |
| 18809108011340 | K093145 | 000 |
| 28809108010593 | K093145 | 000 |