FDA 510(k)

QUADRANT POSTERIOR DENSE

K-Number: K984044 · 1998-12-16

Decision Date1998-12-16

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

QUADRANT POSTERIOR DENSE is the device name listed in this FDA 510(k) record. The listed applicant is Cavex Holland BV. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K984044. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUADRANT POSTERIOR DENSE?

QUADRANT POSTERIOR DENSE is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Cavex Holland BV. The 510(k) number is K984044.

When did QUADRANT POSTERIOR DENSE receive FDA 510(k) clearance?

QUADRANT POSTERIOR DENSE received FDA 510(k) clearance on 1998-12-16, under 510(k) number K984044.

Who is the listed applicant for QUADRANT POSTERIOR DENSE?

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

What is the FDA product code for QUADRANT POSTERIOR DENSE?

The FDA product code for QUADRANT POSTERIOR DENSE is EBF.

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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.