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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 K872734
Device Name MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE
Applicant
Palomex Instrumentarium Corp.
P.O. Box 357
Sf-00101, Helsinki
Finland,  FI
Applicant Contact TIMO RIUKULA
Correspondent
Palomex Instrumentarium Corp.
P.O. Box 357
Sf-00101, Helsinki
Finland,  FI
Correspondent Contact TIMO RIUKULA
Regulation Number892.1710
Classification Product Code
IZH  
Date Received07/09/1987
Decision Date 10/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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