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FDA 510(k) Application Details - K110202
Device Classification Name
Transducer, Ultrasonic, Diagnostic
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510(K) Number
K110202
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD, CT 06902 US
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Contact
KATHERINE Y CHOI
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Regulation Number
892.1570
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Classification Product Code
ITX
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More FDA Info for this Product Code
Date Received
01/24/2011
Decision Date
02/08/2011
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
Y
Expedited Review
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