FDA 510(k), K220596, Wearable Breast Pump (Model S9)
FDA 510(k), K220596, Wearable Breast Pump (Model S9)
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510(K) Number: K220596
Device Name: Wearable Breast Pump (Model S9)
Manufacturer: Shenzhen TPH Technology Co., Ltd.
Device Classification Name: Pump, Breast, Powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 03/01/2022
Decision Date: 05/26/2022
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Wearable Breast Pump (Model S9)
Manufacturer: Shenzhen TPH Technology Co., Ltd.
Device Classification Name: Pump, Breast, Powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 03/01/2022
Decision Date: 05/26/2022
Regulation Medical Specialty: Obstetrics/Gynecology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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