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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 K021945
Device Name PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
Applicant
Planmed OY
100 N. Gray Ave. Suite A
Roselle,  IL  60172
Applicant Contact BOB PIENKOWSKI
Correspondent
Planmed OY
100 N. Gray Ave. Suite A
Roselle,  IL  60172
Correspondent Contact BOB PIENKOWSKI
Regulation Number892.1710
Classification Product Code
IZH  
Date Received06/13/2002
Decision Date 02/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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