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510(k) K250829

Lacevo Wearable Breast Pump (Model S70) by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2025
Date Received
March 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Shenzhen TPH Technology Co., Ltd.

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  • K250368 — Wearable Breast Pump (Model S21) (May 30, 2025)
  • K243508 — Wearable breast pump (model S12A) (April 21, 2025)
  • K250152 — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (April 2, 2025)

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