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FDA 510(k)

GENUCOM

K-Number: K834462 · 1984-02-09

ApplicantFar Orthopedics, Inc.
Decision Date1984-02-09
Product CodeLYH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GENUCOM is the device name listed in this FDA 510(k) record. The listed applicant is Far Orthopedics, Inc.. It received FDA 510(k) clearance on 1984-02-09 under 510(k) number K834462. The device is classified under product code LYH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENUCOM?

GENUCOM is a medical device that received FDA 510(k) clearance on 1984-02-09. The listed applicant is Far Orthopedics, Inc.. The 510(k) number is K834462.

When did GENUCOM receive FDA 510(k) clearance?

GENUCOM received FDA 510(k) clearance on 1984-02-09, under 510(k) number K834462.

Who is the listed applicant for GENUCOM?

The FDA 510(k) record lists Far Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENUCOM?

The FDA product code for GENUCOM is LYH.

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.

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Other records listing Far Orthopedics, Inc. 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.

K860225METRICOM

Related Devices (Code: LYH)

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.

K943197KT1000/S KNEE LIGAMENT ARTHROMETERMedmetric Corp.K942059KT2000 KNEE LIGAMENT ARTHROMETERMedmetric Corp.K881876DYNAMIC CRUCIATE TESTERDyonics, Inc.K812806KT-1000 DEVICEMedmetric Corp.

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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