CORE-SPORT— 510(k) K220081

Substantially Equivalent

Incore Co., Ltd.

FDA 510(k) clearance K220081 for CORE-SPORT, Substantially Equivalent on 2022-09-28. Applicant: Incore Co., Ltd..

Clearance details

Applicant: Incore Co., Ltd.
Product code: Code OTJ
Advisory panel: Gastroenterology, Urology
Date received: 2022-01-10
Decision date: 2022-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

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