Metacem— 510(k) K171449

Substantially Equivalent

Meta Biomed Co., Ltd.

FDA 510(k) clearance K171449 for Metacem, Substantially Equivalent on 2018-05-15. Applicant: Meta Biomed Co., Ltd.. Device class: 2.

Clearance details

Applicant: Meta Biomed Co., Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2017-05-17
Decision date: 2018-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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