BLUESHINE'S GOLD SERIES— 510(k) K110375

Substantially Equivalent

Blueshine Srl

FDA 510(k) clearance K110375 for BLUESHINE'S GOLD SERIES, Substantially Equivalent on 2012-02-23. Applicant: Blueshine Srl. Device class: 2.

Clearance details

Applicant: Blueshine Srl
Product code: Code PDZ
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2011-02-09
Decision date: 2012-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mestre(Ve), IT

Download summary PDF View on FDA.gov ↗

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