MEGA ISQ— 510(k) K132401

Substantially Equivalent

Osstell AB

FDA 510(k) clearance K132401 for MEGA ISQ, Substantially Equivalent on 2014-04-09. Applicant: Osstell AB.

Clearance details

Applicant: Osstell AB
Product code: Code EKX
Advisory panel: Dental
Date received: 2013-08-01
Decision date: 2014-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Alexandria, VA, US

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