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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861527
Device Name COMET COSMIC 203/218
Applicant
Fuyo U.S.A. Co., Ltd.
1400 - 112th SE, Suite 100
Bellevue,  WA  98004
Applicant Contact RANDALL E BOSTRUM
Correspondent
Fuyo U.S.A. Co., Ltd.
1400 - 112th SE, Suite 100
Bellevue,  WA  98004
Correspondent Contact RANDALL E BOSTRUM
Date Received04/24/1986
Decision Date 07/31/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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