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FDA 510(k)

MYERSON/KENSON GP POLYMER

K-Number: K813328 · 1982-02-24

Decision Date1982-02-24
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MYERSON/KENSON GP POLYMER is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-02-24 under 510(k) number K813328. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYERSON/KENSON GP POLYMER?

MYERSON/KENSON GP POLYMER is a medical device that received FDA 510(k) clearance on 1982-02-24. The listed applicant is Howmedica Corp.. The 510(k) number is K813328.

When did MYERSON/KENSON GP POLYMER receive FDA 510(k) clearance?

MYERSON/KENSON GP POLYMER received FDA 510(k) clearance on 1982-02-24, under 510(k) number K813328.

Who is the listed applicant for MYERSON/KENSON GP POLYMER?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYERSON/KENSON GP POLYMER?

The FDA product code for MYERSON/KENSON GP POLYMER is EBD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Howmedica Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EBD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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

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