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510(k) K172842

GCE704 Breast Pump by Globalcare — Product Code HGX

K172842 is an FDA 510(k) premarket notification submitted by Globalcare for the device "GCE704 Breast Pump". The FDA issued a decision of Substantially Equivalent on Jun 18, 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
Jun 18, 2018
Date Received
Sep 19, 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