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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 K010116
Device Name PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
Applicant
Planmed OY
1250 Greenbriar, Suite A
Addison,  IL  60101
Applicant Contact BOB PIENKOWSKI
Correspondent
Planmed OY
1250 Greenbriar, Suite A
Addison,  IL  60101
Correspondent Contact BOB PIENKOWSKI
Regulation Number892.1710
Classification Product Code
IZH  
Date Received01/16/2001
Decision Date 03/15/2001
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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