FDA 510(k) Application Details - K962153

Device Classification Name System, Image Processing, Radiological

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510(K) Number K962153
Device Name System, Image Processing, Radiological
Applicant UNIVERSITY OF WASHINGTON
HEALTH SCIENCES BLDG. RR-616
1959 NE PACIFIC STREET 356422
SEATTLE, WA 98195-6422 US
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Contact FLORENCE H SHEEHAN, M.D.
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/04/1996
Decision Date 01/17/1997
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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