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510(k) K143574

Melodi Prime Breast Pump by Genadyne Biotechnologies, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2015
Date Received
December 17, 2014
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

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