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FDA 510(k) Application Details - K083824
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K083824
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
HUMANSCAN COMPANY, LTD.
16303 PANORMIC WAY
SAN LEANDRO, CA 93478-1116 US
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Contact
GARY ALLSEBROOK
Other 510(k) Applications for this Contact
Regulation Number
892.1570
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Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2008
Decision Date
02/10/2009
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
N
Expedited Review
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