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FDA 510(k) Application Details - K984405
Device Classification Name
Device, Digital Image Storage, Radiological
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.2010
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Classification Product Code
LMB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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