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FDA 510(k) Application Details - K990298
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K990298
Device Name
System, X-Ray, Stationary
Applicant
I.Z.I. MEDICAL PRODUCTS CORP.
P.O. BOX 4341
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
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More FDA Info for this Product Code
Date Received
02/01/1999
Decision Date
03/03/1999
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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