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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty
510(k) Number K191564
Device Name Progenikine Concentrating System 25 mL System
Applicant
Emcyte Corporation
4331 Veronica S. Shoemaker Blvd., Suite 4
Fort Meyers,  FL  33916
Applicant Contact Patrick Pennie
Correspondent
Emcyte Corporation
4331 Veronica S. Shoemaker Blvd., Suite 4
Fort Meyers,  FL  33916
Correspondent Contact Patrick Pennie
Regulation Number878.5040
Classification Product Code
MUU  
Date Received06/13/2019
Decision Date 11/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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