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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K973125
Device Name MAMMOLOADER BY C.M.A. SRL
Applicant
C.M.A.
7916 Kettlewood Ct.
Plano,  TX  75025
Applicant Contact CARL ALLETTO
Correspondent
C.M.A.
7916 Kettlewood Ct.
Plano,  TX  75025
Correspondent Contact CARL ALLETTO
Regulation Number892.1900
Classification Product Code
IXW  
Date Received08/20/1997
Decision Date 10/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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