The following data is part of a premarket notification filed by Haenim Co., Ltd. with the FDA for Powered Breast Pump (models 7v And 7x).
| Device ID | K211016 |
| 510k Number | K211016 |
| Device Name: | Powered Breast Pump (Models 7V And 7X) |
| Classification | Pump, Breast, Powered |
| Applicant | Haenim Co., Ltd. 15, Saryeom-ro 21beon-gil, Seo-gu Incheon, KR 22742 |
| Contact | Dae Won Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-05 |
| Decision Date | 2022-06-29 |