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FDA 510(k)

OSSEOINTEGRATED FIXTURES-TISSUE INTEGR

K-Number: K841551 · 1984-06-22

ApplicantBofors Nobelpharma, Inc.
Decision Date1984-06-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEOINTEGRATED FIXTURES-TISSUE INTEGR is the device name listed in this FDA 510(k) record. The listed applicant is Bofors Nobelpharma, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K841551. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSEOINTEGRATED FIXTURES-TISSUE INTEGR?

OSSEOINTEGRATED FIXTURES-TISSUE INTEGR is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Bofors Nobelpharma, Inc.. The 510(k) number is K841551.

When did OSSEOINTEGRATED FIXTURES-TISSUE INTEGR receive FDA 510(k) clearance?

OSSEOINTEGRATED FIXTURES-TISSUE INTEGR received FDA 510(k) clearance on 1984-06-22, under 510(k) number K841551.

Who is the listed applicant for OSSEOINTEGRATED FIXTURES-TISSUE INTEGR?

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

What is the FDA product code for OSSEOINTEGRATED FIXTURES-TISSUE INTEGR?

The FDA product code for OSSEOINTEGRATED FIXTURES-TISSUE INTEGR is DZE.

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Other records listing Bofors Nobelpharma, 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: DZE)

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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