IS3— 510(k) K180527

Substantially Equivalent

Hiossen, Inc.

FDA 510(k) clearance K180527 for IS3, Substantially Equivalent on 2018-05-16. Applicant: Hiossen, Inc..

Clearance details

Applicant: Hiossen, Inc.
Product code: Code EKX
Advisory panel: Dental
Date received: 2018-02-28
Decision date: 2018-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fariless Hills, PA, US

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