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FDA 510(k) Application Details - K962153
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
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.
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
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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