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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 K932672
Device Name MAMMOMAT 300 AND MAMMOMAT 3000
Original Applicant
186 wood avenue south
iselin,  NJ  08830
Original Contact george katzebnbach
Regulation Number892.1710
Classification Product Code
Date Received06/02/1993
Decision Date 09/14/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No