TANYX— 510(k) K123866

Substantially Equivalent

Medecell Us, Inc.

FDA 510(k) clearance K123866 for TANYX, Substantially Equivalent on 2013-09-13. Applicant: Medecell Us, Inc..

Clearance details

Applicant: Medecell Us, Inc.
Product code: Code NUH
Advisory panel: Neurology
Date received: 2012-12-17
Decision date: 2013-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, VA, US

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