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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 K001171
Device Name DELTA 16 TACT
Applicant
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
milwaukee,  WI  53207 -6025
Applicant Contact max lindert
Correspondent
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
milwaukee,  WI  53207 -6025
Correspondent Contact max lindert
Regulation Number892.1710
Classification Product Code
IZH  
Date Received04/11/2000
Decision Date 05/12/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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