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FDA 510(k)

ALLOGRAN-R

K-Number: K061311 · 2006-09-22

ApplicantBiocomposites, Ltd.
Decision Date2006-09-22
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALLOGRAN-R is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2006-09-22 under 510(k) number K061311. 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 ALLOGRAN-R?

ALLOGRAN-R is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K061311.

When did ALLOGRAN-R receive FDA 510(k) clearance?

ALLOGRAN-R received FDA 510(k) clearance on 2006-09-22, under 510(k) number K061311.

Who is the listed applicant for ALLOGRAN-R?

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

What is the FDA product code for ALLOGRAN-R?

The FDA product code for ALLOGRAN-R is 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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