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FDA 510(k)

BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM

K-Number: K053213 · 2006-07-06

ApplicantBerkeley Advanced Biomaterials, Inc.
Decision Date2006-07-06
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM 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 2006-07-06 under 510(k) number K053213. 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 BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM?

BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM is a medical device that received FDA 510(k) clearance on 2006-07-06. The listed applicant is Berkeley Advanced Biomaterials, Inc.. The 510(k) number is K053213.

When did BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM receive FDA 510(k) clearance?

BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM received FDA 510(k) clearance on 2006-07-06, under 510(k) number K053213.

Who is the listed applicant for BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM?

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 BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM?

The FDA product code for BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM is MQV.

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K113791B-GENIN, R-GENINK091912B-GENIN AND R-GENINK092046BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTYK051914GENEROS 80, GENEROS 60K051695MARROW PLUS (M+)K050666GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES

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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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