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510(k) K121218

HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, by Andrew Technologies, LLC — Product Code QPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2012
Date Received
April 23, 2012
Clearance Type
Special
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

Other clearances by Andrew Technologies, LLC

  • K130152 — HYDRASOLVE LIPOPLASTY SYSTEM (April 18, 2013)
  • K092066 — PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE (April 12, 2010)

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