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FDA 510(k) Application Details - K973090
Device Classification Name
System, Digital Image Communications, Radiological
More FDA Info for this Device
510(K) Number
K973090
Device Name
System, Digital Image Communications, Radiological
Applicant
PROGRAM S.R.L.
719 CATALPA AVE.
TEANECK, NJ 07666 US
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Contact
DIANA UPTON
Other 510(k) Applications for this Contact
Regulation Number
892.2020
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Classification Product Code
LMD
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More FDA Info for this Product Code
Date Received
08/18/1997
Decision Date
10/28/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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