A1C GEAR SYSTEM— 510(k) K130014

Substantially Equivalent

Sakae Corporation

FDA 510(k) clearance K130014 for A1C GEAR SYSTEM, Substantially Equivalent on 2014-04-04. Applicant: Sakae Corporation. Device class: 2.

Clearance details

Applicant: Sakae Corporation
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2013-01-02
Decision date: 2014-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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