The following data is part of a premarket notification filed by Unimom Co. with the FDA for Opera, Opera Eco.
| Device ID | K190810 |
| 510k Number | K190810 |
| Device Name: | OPERA, OPERA Eco |
| Classification | Pump, Breast, Powered |
| Applicant | Unimom Co. 110-19, Gajangsaneopseobuk-ro Osan-si, KR 18102 |
| Contact | Sang-hyun Hong |
| Correspondent | Sang-hyun Hong Unimom Co. 110-19, Gajangsaneopseobuk-ro Osan-si, KR 18102 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809224872460 | K190810 | 000 |