Marco Ultra M3, Marco Ultra M4— 510(k) K162636

Substantially Equivalent

Takagi Seiko Co., Ltd.

FDA 510(k) clearance K162636 for Marco Ultra M3, Marco Ultra M4, Substantially Equivalent on 2017-04-14. Applicant: Takagi Seiko Co., Ltd..

Clearance details

Applicant: Takagi Seiko Co., Ltd.
Product code: Code HJO
Advisory panel: Ophthalmic
Date received: 2016-09-21
Decision date: 2017-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nakano, JP

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