LSFG-NAVI— 510(k) K153239

Substantially Equivalent

Softcare Co., Ltd.

FDA 510(k) clearance K153239 for LSFG-NAVI, Substantially Equivalent on 2016-05-12. Applicant: Softcare Co., Ltd..

Clearance details

Applicant: Softcare Co., Ltd.
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2015-11-09
Decision date: 2016-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fukutsu, JP

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