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FDA 510(k) Application Details - K013170
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K013170
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
SONOTECH, INC.
774 MARINE DR.
BELLINGHAM, WA 98225 US
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Contact
MARGARET J LARSON
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
09/24/2001
Decision Date
11/13/2001
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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