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FDA 510(k)

APACERAM BONE GRAFT SUBSTITUTE

K-Number: K071912 · 2007-10-29

ApplicantPentax Corp.
Decision Date2007-10-29
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APACERAM BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Corp.. It received FDA 510(k) clearance on 2007-10-29 under 510(k) number K071912. 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 APACERAM BONE GRAFT SUBSTITUTE?

APACERAM BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2007-10-29. The listed applicant is Pentax Corp.. The 510(k) number is K071912.

When did APACERAM BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

APACERAM BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2007-10-29, under 510(k) number K071912.

Who is the listed applicant for APACERAM BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for APACERAM BONE GRAFT SUBSTITUTE?

The FDA product code for APACERAM BONE GRAFT SUBSTITUTE 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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