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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Changer, Radiographic Film/Cassette
510(k) Number K862575
Device Name UNIVERSAL STAND FOR FILM CHANGER
Applicant
Canon USA, Inc.
One Jericho Plaza
Jericho,  NY  11753 -1000
Applicant Contact MR. M TAMADA
Correspondent
Canon USA, Inc.
One Jericho Plaza
Jericho,  NY  11753 -1000
Correspondent Contact MR. M TAMADA
Regulation Number892.1860
Classification Product Code
KPX  
Date Received07/07/1986
Decision Date 07/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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