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510(k) K161372

The Red Head Collection Device, The Jordy Connection System by Miami Fat Supply — Product Code MUU

K161372 is an FDA 510(k) premarket notification submitted by Miami Fat Supply for the device "The Red Head Collection Device, The Jordy Connection System". The FDA issued a decision of Substantially Equivalent on February 24, 2017. The device falls under product code MUU (System, Suction, Lipoplasty), a Class II device regulated under 21 CFR 878.5040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2017
Date Received
May 17, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

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FDA data resources