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510(k) K222726

Smartpump 3.0 Double Electric Breast Pump by Lansinoh Laboratories — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2022
Date Received
September 8, 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 Lansinoh Laboratories

  • K230469 — Compact Wearable Pump (June 30, 2023)

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