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FDA 510(k)

B-GENIN, R-GENIN

K-Number: K113791 · 2012-03-15

ApplicantBerkeley Advanced Biomaterials, Inc.
Decision Date2012-03-15
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

B-GENIN, R-GENIN 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 2012-03-15 under 510(k) number K113791. 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 B-GENIN, R-GENIN?

B-GENIN, R-GENIN is a medical device that received FDA 510(k) clearance on 2012-03-15. The listed applicant is Berkeley Advanced Biomaterials, Inc.. The 510(k) number is K113791.

When did B-GENIN, R-GENIN receive FDA 510(k) clearance?

B-GENIN, R-GENIN received FDA 510(k) clearance on 2012-03-15, under 510(k) number K113791.

Who is the listed applicant for B-GENIN, R-GENIN?

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 B-GENIN, R-GENIN?

The FDA product code for B-GENIN, R-GENIN 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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