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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 U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Applicant Contact UCHIL
Correspondent
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
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
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