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510(k) K150134

Basic, Dominant Flex, KV-6 by Medela AG — Product Code QPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2015
Date Received
January 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty For Removal
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

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