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510(k) K173699

The Pump by Babyation by Babyation, LLC — Product Code HGX

K173699 is an FDA 510(k) premarket notification submitted by Babyation, LLC for the device "The Pump by Babyation". The FDA issued a decision of Substantially Equivalent on Apr 4, 2018. 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
Apr 4, 2018
Date Received
Dec 4, 2017
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