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FDA 510(k)

COPELAND RESURFACING HEADS

K-Number: K003044 · 2000-12-13

ApplicantBiomet, Inc.
Decision Date2000-12-13
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COPELAND RESURFACING 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 2000-12-13 under 510(k) number K003044. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPELAND RESURFACING HEADS?

COPELAND RESURFACING HEADS is a medical device that received FDA 510(k) clearance on 2000-12-13. The listed applicant is Biomet, Inc.. The 510(k) number is K003044.

When did COPELAND RESURFACING HEADS receive FDA 510(k) clearance?

COPELAND RESURFACING HEADS received FDA 510(k) clearance on 2000-12-13, under 510(k) number K003044.

Who is the listed applicant for COPELAND RESURFACING 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 COPELAND RESURFACING HEADS?

The FDA product code for COPELAND RESURFACING HEADS is HSD.

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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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