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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 K955411
Device Name DELTA 16
Applicant
INSTRUMENTARIUM IMAGING, INC.
P.O. BOX 20 (NAHKELANTIE 160)
FIN-04301
TUUSULA, FINLAND,  FI
Applicant Contact RISTO MYNTTINEN
Correspondent
INSTRUMENTARIUM IMAGING, INC.
P.O. BOX 20 (NAHKELANTIE 160)
FIN-04301
TUUSULA, FINLAND,  FI
Correspondent Contact RISTO MYNTTINEN
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/27/1995
Decision Date 03/21/1996
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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