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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oil, Clearing
510(k) Number K853861
Device Name CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105
Applicant
Canon USA, Inc.
One Jericho Plaza
Jericho,  NY  11753 -1000
Applicant Contact TAMADA
Correspondent
Canon USA, Inc.
One Jericho Plaza
Jericho,  NY  11753 -1000
Correspondent Contact TAMADA
Regulation Number864.4010
Classification Product Code
IJZ  
Date Received09/17/1985
Decision Date 10/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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