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FDA 510(k) Application Details - K081919
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K081919
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
FUKUDA DENSHI CO., LTD.
17725 N.E. 65TH STREET
BLDG C
REDMOND, WA 98052-4911 US
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Contact
LORAN VAN NOY
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
ITX
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More FDA Info for this Product Code
Date Received
07/07/2008
Decision Date
09/09/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
Y
Expedited Review
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