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FDA 510(k)

CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY

K-Number: K040405 · 2004-03-05

ApplicantBerkeley Advanced Biomaterials, Inc.
Decision Date2004-03-05
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY 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 2004-03-05 under 510(k) number K040405. 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 PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY?

CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is Berkeley Advanced Biomaterials, Inc.. The 510(k) number is K040405.

When did CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY receive FDA 510(k) clearance?

CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY received FDA 510(k) clearance on 2004-03-05, under 510(k) number K040405.

Who is the listed applicant for CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY?

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 PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY?

The FDA product code for CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY is MQV.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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