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510(k) K211016

Powered Breast Pump (Models 7V and 7X) by Haenim Co., Ltd. — Product Code HGX

K211016 is an FDA 510(k) premarket notification submitted by Haenim Co., Ltd. for the device "Powered Breast Pump (Models 7V and 7X)". The FDA issued a decision of Substantially Equivalent on Jun 29, 2022. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 29, 2022
Date Received
Apr 5, 2021
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
510(k)

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FDA data resources