Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
FDA 510(k) clearance K193449 · decided 2020-09-11
Clearance details
- K-number
- K193449
- Device name
- Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
- Applicant
- Guangdong Horigen Mother & Baby Products Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-13
- Decision date
- 2020-09-11
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shantou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.