KENZ-GELECT— 510(k) K812263

Substantially Equivalent

Suzuken Co., Ltd.

FDA 510(k) clearance K812263 for KENZ-GELECT, Substantially Equivalent on 1981-11-02. Applicant: Suzuken Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzuken Co., Ltd.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 1981-08-13
Decision date: 1981-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.