PUREGRAFT 850/PURE SYSTEM— 510(k) K113255

Name: FDA 510(k) clearance K113255
Creator: U.S. Food and Drug Administration
Published: 2012-03-07

Substantially Equivalent

Cytori Therapeutics, Inc.

FDA 510(k) clearance K113255 for PUREGRAFT 850/PURE SYSTEM, Substantially Equivalent on 2012-03-07. Applicant: Cytori Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Cytori Therapeutics, Inc.
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2011-11-03
Decision date: 2012-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.