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FDA 510(k)

WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER

K-Number: K083274 · 2009-01-08

ApplicantBiocompatibles, Inc.
Decision Date2009-01-08
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles, Inc.. It received FDA 510(k) clearance on 2009-01-08 under 510(k) number K083274. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER?

WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER is a medical device that received FDA 510(k) clearance on 2009-01-08. The listed applicant is Biocompatibles, Inc.. The 510(k) number is K083274.

When did WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER receive FDA 510(k) clearance?

WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER received FDA 510(k) clearance on 2009-01-08, under 510(k) number K083274.

Who is the listed applicant for WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER?

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

What is the FDA product code for WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER?

The FDA product code for WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER is KXK.

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Other records listing Biocompatibles, 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.

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Related Devices (Code: KXK)

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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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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