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FDA 510(k)

CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P

K-Number: K022622 · 2003-01-09

ApplicantBerkeley Advanced Biomaterials, Inc.
Decision Date2003-01-09
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P 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 2003-01-09 under 510(k) number K022622. 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 CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P?

CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P is a medical device that received FDA 510(k) clearance on 2003-01-09. The listed applicant is Berkeley Advanced Biomaterials, Inc.. The 510(k) number is K022622.

When did CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P receive FDA 510(k) clearance?

CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P received FDA 510(k) clearance on 2003-01-09, under 510(k) number K022622.

Who is the listed applicant for CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P?

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 CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P?

The FDA product code for CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P 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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