NANOGEN— 510(k) K102208

Substantially Equivalent

Orthogen, LLC

FDA 510(k) clearance K102208 for NANOGEN, Substantially Equivalent on 2011-05-06. Applicant: Orthogen, LLC. Device class: 2.

Clearance details

Applicant: Orthogen, LLC
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-08-05
Decision date: 2011-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, NJ, 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.