PROCEM— 510(k) K140644

Substantially Equivalent

Ototronix, LLC

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

Clearance details

Applicant: Ototronix, LLC
Product code: Code NEA
Advisory panel: Dental
Date received: 2014-03-13
Decision date: 2014-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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