The following data is part of a premarket notification filed by Unimom Co. with the FDA for Minuet Lcd, Minuet Lcd Eco.
Device ID | K180075 |
510k Number | K180075 |
Device Name: | MINUET LCD, MINUET LCD Eco |
Classification | Pump, Breast, Powered |
Applicant | Unimom Co. 110-19 Gajangsaneopseobuk-ro Osan-si, KR 18102 |
Contact | Hong Sang-hyun |
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 | 2018-01-10 |
Decision Date | 2018-08-06 |
Summary: | summary |