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FDA 510(k)

VALUETRODE

K-Number: K970426 · 1997-05-09

ApplicantAxelgaard Mfg. Co., Ltd.
Decision Date1997-05-09
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VALUETRODE is the device name listed in this FDA 510(k) record. The listed applicant is Axelgaard Mfg. Co., Ltd.. It received FDA 510(k) clearance on 1997-05-09 under 510(k) number K970426. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALUETRODE?

VALUETRODE is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Axelgaard Mfg. Co., Ltd.. The 510(k) number is K970426.

When did VALUETRODE receive FDA 510(k) clearance?

VALUETRODE received FDA 510(k) clearance on 1997-05-09, under 510(k) number K970426.

Who is the listed applicant for VALUETRODE?

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

What is the FDA product code for VALUETRODE?

The FDA product code for VALUETRODE is GXY.

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Other records listing Axelgaard Mfg. Co., Ltd. as applicant

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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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