SOPIX 2— 510(k) K092329

Substantially Equivalent

Sopro

FDA 510(k) clearance K092329 for SOPIX 2, Substantially Equivalent on 2010-07-20. Applicant: Sopro. Device class: 2.

Clearance details

Applicant: Sopro
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2009-08-04
Decision date: 2010-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Laurel, NJ, US

Download summary PDF View on FDA.gov ↗

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