Progenikine Concentrating System 25 mL System— 510(k) K191564

Name: FDA 510(k) clearance K191564
Creator: U.S. Food and Drug Administration
Published: 2019-11-07

Substantially Equivalent

Emcyte Corporation

FDA 510(k) clearance K191564 for Progenikine Concentrating System 25 mL System, Substantially Equivalent on 2019-11-07. Applicant: Emcyte Corporation. Device class: 2.

Clearance details

Applicant: Emcyte Corporation
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2019-06-13
Decision date: 2019-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Meyers, FL, US

Download summary PDF View on FDA.gov ↗

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