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FDA 510(k)

KENZ-GELECT GEL PAD

K-Number: K820991 · 1982-04-26

ApplicantSuzuken Co., Ltd.
Decision Date1982-04-26
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KENZ-GELECT GEL PAD 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 1982-04-26 under 510(k) number K820991. 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 GEL PAD?

KENZ-GELECT GEL PAD is a medical device that received FDA 510(k) clearance on 1982-04-26. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K820991.

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

KENZ-GELECT GEL PAD received FDA 510(k) clearance on 1982-04-26, under 510(k) number K820991.

Who is the listed applicant for KENZ-GELECT GEL PAD?

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 GEL PAD?

The FDA product code for KENZ-GELECT GEL PAD 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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