Progenikine Concentrating System 25 ML System

System, Suction, Lipoplasty

Emcyte Corporation

The following data is part of a premarket notification filed by Emcyte Corporation with the FDA for Progenikine Concentrating System 25 Ml System.

Pre-market Notification Details

Device IDK191564
501k NumberK191564
Device Name:Progenikine Concentrating System 25 ML System
ClassificationSystem, Suction, Lipoplasty
Applicant Emcyte Corporation 4331 Veronica S. Shoemaker Blvd, Suite 4 Fort Meyers,  FL  33916
ContactPatrick Pennie
CorrespondentPatrick Pennie
Emcyte Corporation 4331 Veronica S. Shoemaker Blvd, Suite 4 Fort Meyers,  FL  33916
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-13
Decision Date2019-11-07

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