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FDA 510(k) Application Details - K033507
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K033507
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
PARAMED SRL
719 CATALPA AVENUE
TEANECK, NJ 07666 US
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Contact
DIANA UPTON
Other 510(k) Applications for this Contact
Regulation Number
892.1000
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Classification Product Code
LNH
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More FDA Info for this Product Code
Date Received
11/05/2003
Decision Date
01/20/2004
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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