510(k) K180075

MINUET LCD, MINUET LCD eco by Unimom.Co — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2018
Date Received
January 10, 2018
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