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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 K002472
Device Name DELTA 32 AND DELTA 32 TACT
Applicant
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207 -6025
Applicant Contact TOMMI JOKINIEMI
Correspondent
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207 -6025
Correspondent Contact TOMMI JOKINIEMI
Regulation Number892.1710
Classification Product Code
IZH  
Date Received08/11/2000
Decision Date 11/29/2000
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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