PROCEM— 510(k) K140644

Substantially Equivalent

Ototronix, LLC

FDA 510(k) clearance K140644 for PROCEM, Substantially Equivalent on 2014-06-19. Applicant: Ototronix, LLC. Device class: 2.

Clearance details

Applicant: Ototronix, LLC
Product code: Code NEA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2014-03-13
Decision date: 2014-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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.