FDA 510(k) Application Details - K984405

Device Classification Name Device, Digital Image Storage, Radiological

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510(K) Number K984405
Device Name Device, Digital Image Storage, Radiological
Applicant INTRACOM CORP.
1309 S. MARY AVE.
SUNNYVALE, CA 94087 US
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Contact JAMES A NATIONS
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Regulation Number 892.2010

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Classification Product Code LMB
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Date Received 12/09/1998
Decision Date 02/08/1999
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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