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FDA 510(k)

KENZ-GELECT

K-Number: K812263 · 1981-11-02

ApplicantSuzuken Co., Ltd.
Decision Date1981-11-02
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KENZ-GELECT is the device name listed in this FDA 510(k) record. The listed applicant is Suzuken Co., Ltd.. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812263. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENZ-GELECT?

KENZ-GELECT is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K812263.

When did KENZ-GELECT receive FDA 510(k) clearance?

KENZ-GELECT received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812263.

Who is the listed applicant for KENZ-GELECT?

The FDA 510(k) record lists Suzuken Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENZ-GELECT?

The FDA product code for KENZ-GELECT is GYB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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