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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 K953902
Device Name GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
Applicant
Medical Marketing Intl., Inc.
12748 E. Millburn Ave.
Baton Rouge,  LA  70815
Applicant Contact EDWARD C CHEEK
Correspondent
Medical Marketing Intl., Inc.
12748 E. Millburn Ave.
Baton Rouge,  LA  70815
Correspondent Contact EDWARD C CHEEK
Regulation Number892.1710
Classification Product Code
IZH  
Date Received08/18/1995
Decision Date 03/19/1997
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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