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FDA 510(k)

COMFORT - CUF

K-Number: K852978 · 1986-01-14

ApplicantDynasty Instruments, Ltd.
Decision Date1986-01-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMFORT - CUF is the device name listed in this FDA 510(k) record. The listed applicant is Dynasty Instruments, Ltd.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K852978. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT - CUF?

COMFORT - CUF is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Dynasty Instruments, Ltd.. The 510(k) number is K852978.

When did COMFORT - CUF receive FDA 510(k) clearance?

COMFORT - CUF received FDA 510(k) clearance on 1986-01-14, under 510(k) number K852978.

Who is the listed applicant for COMFORT - CUF?

The FDA 510(k) record lists Dynasty Instruments, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT - CUF?

The FDA product code for COMFORT - CUF is DXN.

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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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