FDA 510(k) Application Details - K984252

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K984252
Device Name Digitizer, Image, Radiological
Applicant IMATION CORP.
1 IMATION PLACE
OAKDALE, MN 55128 US
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Contact STEPHEN G SLAVENS
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 11/27/1998
Decision Date 01/25/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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