The following data is part of a premarket notification filed by Guangdong Horigen Mother & Baby Products Co., Ltd with the FDA for Electric Breast Pump (model Kp033_01), Electric Double Breast Pump (model Kp053_01).
| Device ID | K193449 |
| 510k Number | K193449 |
| Device Name: | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) |
| Classification | Pump, Breast, Powered |
| Applicant | Guangdong Horigen Mother & Baby Products Co., Ltd No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District Shantou, CN 515100 |
| Contact | Jun Deng |
| Correspondent | Jun Deng Guangdong Horigen Mother & Baby Products Co., Ltd No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District Shantou, CN 515100 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-13 |
| Decision Date | 2020-09-11 |