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FDA 510(k)

THE NEW BIO-MOORE ENDO HEADS

K-Number: K984028 · 1999-01-19

ApplicantBiomet, Inc.
Decision Date1999-01-19
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE NEW BIO-MOORE ENDO HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1999-01-19 under 510(k) number K984028. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE NEW BIO-MOORE ENDO HEADS?

THE NEW BIO-MOORE ENDO HEADS is a medical device that received FDA 510(k) clearance on 1999-01-19. The listed applicant is Biomet, Inc.. The 510(k) number is K984028.

When did THE NEW BIO-MOORE ENDO HEADS receive FDA 510(k) clearance?

THE NEW BIO-MOORE ENDO HEADS received FDA 510(k) clearance on 1999-01-19, under 510(k) number K984028.

Who is the listed applicant for THE NEW BIO-MOORE ENDO HEADS?

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

What is the FDA product code for THE NEW BIO-MOORE ENDO HEADS?

The FDA product code for THE NEW BIO-MOORE ENDO HEADS is KWL.

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Related Devices (Code: KWL)

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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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