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510(k) K190810

OPERA, OPERA eco by Unimom.Co — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2019
Date Received
March 29, 2019
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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