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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K953974
Device Name CAMVISION 1000
Applicant
Medivision Medical Imaging, Ltd.
P.O. Box 479
Stoughton,  MA  02072
Applicant Contact RICHARD A DOMAINGUE
Correspondent
Medivision Medical Imaging, Ltd.
P.O. Box 479
Stoughton,  MA  02072
Correspondent Contact RICHARD A DOMAINGUE
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/23/1995
Decision Date 09/09/1996
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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