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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Culdoscopic (And Accessories)
510(k) Number K844053
Device Name CANON 60 DEGREE FUNDUS CAMERA CF-60S
Applicant
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Applicant Contact UCHIL
Correspondent
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Correspondent Contact UCHIL
Regulation Number884.4160
Classification Product Code
HFI  
Date Received10/18/1984
Decision Date 12/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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