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FDA 510(k)

COMET COSMIC 203/218

K-Number: K861527 · 1986-07-31

ApplicantFuyo U.S.A. Co., Ltd.
Decision Date1986-07-31
Product Code
DecisionSubstantially Equivalent for Some Indications

Device Summary

COMET COSMIC 203/218 is the device name listed in this FDA 510(k) record. The listed applicant is Fuyo U.S.A. Co., Ltd.. It received FDA 510(k) clearance on 1986-07-31 under 510(k) number K861527. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the COMET COSMIC 203/218?

COMET COSMIC 203/218 is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is Fuyo U.S.A. Co., Ltd.. The 510(k) number is K861527.

When did COMET COSMIC 203/218 receive FDA 510(k) clearance?

COMET COSMIC 203/218 received FDA 510(k) clearance on 1986-07-31, under 510(k) number K861527.

Who is the listed applicant for COMET COSMIC 203/218?

The FDA 510(k) record lists Fuyo U.S.A. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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

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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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