K861527Substantially Equivalent for Some Indications

Comet Cosmic 203/218

Name: K861527 Comet Cosmic 203/218
Creator: Fuyo U.S.A. Co., Ltd.
Published: 1986-07-31
License: https://open.fda.gov/license/

Fuyo U.S.A. Co., Ltd., Bellevue WA / Traditional, Substantially Equivalent for Some Indications

FDA source

K861527 is the FDA 510(k) clearance record for COMET COSMIC 203/218, cleared for Fuyo U.S.A. Co., Ltd. on 1986-07-31. FDA records list one 510(k) clearance for Fuyo U.S.A. Co., Ltd. As of 2026-09-10, FDA records show no recalls naming K861527.

Clearance record

Decision date: 1986-07-31
Received: 1986-04-24 (98 days to decision)
Review panel: Unknown
Applicant: Fuyo U.S.A. Co., Ltd. 1400 - 112th SE, Suite 100, Bellevue WA
Third party review: No