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FDA 510(k)

CORIN UNIPOLAR MODULAR HEAD

K-Number: K063791 · 2007-04-03

ApplicantCorin USA
Decision Date2007-04-03
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORIN UNIPOLAR MODULAR HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2007-04-03 under 510(k) number K063791. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORIN UNIPOLAR MODULAR HEAD?

CORIN UNIPOLAR MODULAR HEAD is a medical device that received FDA 510(k) clearance on 2007-04-03. The listed applicant is Corin USA. The 510(k) number is K063791.

When did CORIN UNIPOLAR MODULAR HEAD receive FDA 510(k) clearance?

CORIN UNIPOLAR MODULAR HEAD received FDA 510(k) clearance on 2007-04-03, under 510(k) number K063791.

Who is the listed applicant for CORIN UNIPOLAR MODULAR HEAD?

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

What is the FDA product code for CORIN UNIPOLAR MODULAR HEAD?

The FDA product code for CORIN UNIPOLAR MODULAR HEAD is KWL.

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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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