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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 K901558
Device Name GIOTTO MAMMOGRAPHY HF
Applicant
Medical Device Marketing Network, Inc.
P.O. Box 5206
Cleveland,  OH  44095
Applicant Contact JOHN PEREZ
Correspondent
Medical Device Marketing Network, Inc.
P.O. Box 5206
Cleveland,  OH  44095
Correspondent Contact JOHN PEREZ
Regulation Number892.1710
Classification Product Code
IZH  
Date Received04/03/1990
Decision Date 07/03/1990
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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