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FDA 510(k)

QUADRANT UNICHEM

K-Number: K983751 · 1998-11-30

ApplicantCavex Holland BV
Decision Date1998-11-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUADRANT UNICHEM 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 1998-11-30 under 510(k) number K983751. 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 UNICHEM?

QUADRANT UNICHEM is a medical device that received FDA 510(k) clearance on 1998-11-30. The listed applicant is Cavex Holland BV. The 510(k) number is K983751.

When did QUADRANT UNICHEM receive FDA 510(k) clearance?

QUADRANT UNICHEM received FDA 510(k) clearance on 1998-11-30, under 510(k) number K983751.

Who is the listed applicant for QUADRANT UNICHEM?

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 UNICHEM?

The FDA product code for QUADRANT UNICHEM is EBF.

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Other records listing Cavex Holland BV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073539PROVISA CEMK072245EMULATE ADVANCEDK062400IMPRESSIX, COLORCHANGE ALGINATEK061267SIMULATE, COLOR CHANGE ALGINATEK052455IMPRESSIXK051207CAVEX ORTHOTRACE

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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