Plexus— 510(k) K191107

Substantially Equivalent

Alleva Medical (D.G), Ltd.

FDA 510(k) clearance K191107 for Plexus, Substantially Equivalent on 2019-08-27. Applicant: Alleva Medical (D.G), Ltd..

Clearance details

Applicant: Alleva Medical (D.G), Ltd.
Product code: Code JOW
Advisory panel: Cardiovascular
Date received: 2019-04-26
Decision date: 2019-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shek Mun, HK

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