THE GYNOCULAR— 510(k) K132423

Substantially Equivalent

Gynius AB

FDA 510(k) clearance K132423 for THE GYNOCULAR, Substantially Equivalent on 2014-04-08. Applicant: Gynius AB.

Clearance details

Applicant: Gynius AB
Product code: Code HEX
Advisory panel: Obstetrics/Gynecology
Date received: 2013-08-05
Decision date: 2014-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

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