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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K121963
Device Name PLANMED NUANCE DIGIGUIDE
Applicant
PLANMED OY
ASENTAJANKATU 6
SORVAAJANKATU 7
HELSINKI,  FI FI-00880
Applicant Contact LARS MORING
Correspondent
PLANMED OY
ASENTAJANKATU 6
SORVAAJANKATU 7
HELSINKI,  FI FI-00880
Correspondent Contact LARS MORING
Regulation Number892.1715
Classification Product Code
MUE  
Date Received07/05/2012
Decision Date 11/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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