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510(k) K220309

Wearable Breast Pump (Model S10) by Shenzhen Lutejiacheng Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2022
Date Received
February 2, 2022
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 Lutejiacheng Technology Co., Ltd.

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  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)