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FDA 510(k)

TRI-OSTETIC

K-Number: K041889 · 2004-08-19

ApplicantBerkeley Advanced Biomaterials, Inc.
Decision Date2004-08-19
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRI-OSTETIC is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Advanced Biomaterials, Inc.. It received FDA 510(k) clearance on 2004-08-19 under 510(k) number K041889. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-OSTETIC?

TRI-OSTETIC is a medical device that received FDA 510(k) clearance on 2004-08-19. The listed applicant is Berkeley Advanced Biomaterials, Inc.. The 510(k) number is K041889.

When did TRI-OSTETIC receive FDA 510(k) clearance?

TRI-OSTETIC received FDA 510(k) clearance on 2004-08-19, under 510(k) number K041889.

Who is the listed applicant for TRI-OSTETIC?

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

What is the FDA product code for TRI-OSTETIC?

The FDA product code for TRI-OSTETIC is MQV.

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Other records listing Berkeley Advanced Biomaterials, Inc. as applicant

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Related Devices (Code: MQV)

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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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