FDA 510(k) Application Details - K972822

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K972822
Device Name Camera, Multi Format, Radiological
Applicant IMATION ENTERPRISES CORP.
3M CENTER, BLDG. 235-2B-23
ST. PAUL, MN 55144-1000 US
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Contact STEPHEN G SLAVENS
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 07/30/1997
Decision Date 11/19/1997
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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