The following data is part of a premarket notification filed by Uzinmedicare Co. with the FDA for Synergy Gold (sg) Portable (models Mm011450 And Mm011460).
| Device ID | K210124 |
| 510k Number | K210124 |
| Device Name: | Synergy Gold (SG) Portable (Models MM011450 And MM011460) |
| Classification | Pump, Breast, Powered |
| Applicant | Uzinmedicare Co. 56, Dongtansandan 5-Gil,Dongtan-Myeon Hwaseong-Si, KR 18487 |
| Contact | Nathan Ahn |
| Correspondent | Adrienne R. Lenz 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809108014624 | K210124 | 000 |
| 28809108016465 | K210124 | 000 |
| 08809108016546 | K210124 | 000 |
| 08809108016539 | K210124 | 000 |
| 28809108015765 | K210124 | 000 |