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FDA 510(k) Application Details - K050320
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K050320
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
ASCENDIA MEDTECH AB
485 LAROE ROAD
CHESTER, NY 10918 US
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Contact
JANE B CAMPBELL
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/09/2005
Decision Date
08/15/2005
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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