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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, Mammographic
510(k) Number K844119
Device Name MAMMOGRAPH III
Applicant
American Medical Imports, Inc.
P.O. Box 950
Sedona,  AZ  86336
Applicant Contact ARTHUR WATTS
Correspondent
American Medical Imports, Inc.
P.O. Box 950
Sedona,  AZ  86336
Correspondent Contact ARTHUR WATTS
Regulation Number892.1710
Classification Product Code
IZH  
Date Received10/23/1984
Decision Date 07/19/1985
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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