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510(k) K170329

Basic, Dominant Flex by Modela AG — Product Code QPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2017
Date Received
February 2, 2017
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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