Qraypen— 510(k) K183121

Substantially Equivalent

AIOBIO Co., Ltd.

FDA 510(k) clearance K183121 for Qraypen, Substantially Equivalent on 2019-07-18. Applicant: AIOBIO Co., Ltd..

Clearance details

Applicant: AIOBIO Co., Ltd.
Product code: Code EIA
Advisory panel: Dental
Date received: 2018-11-09
Decision date: 2019-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

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