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FDA 510(k) Application Details - K953773
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K953773
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
MEDISON AMERICA, INC.
5880 WEST LAS POSITAS BLVD.,
SUITE 52
PLEASANTON, CA 94566 US
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Contact
MARK F HAYWARD
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Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
08/14/1995
Decision Date
03/14/1996
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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