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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 K993740
Device Name MAMEX
Applicant
Medical Systems Group
11550 W. King St.
Franklin Park,  IL  60131
Applicant Contact JEFFREY N MOELLER
Correspondent
Medical Systems Group
11550 W. King St.
Franklin Park,  IL  60131
Correspondent Contact JEFFREY N MOELLER
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/04/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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