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FDA 510(k) Application Details - K022860
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K022860
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT, CA 94538 US
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Contact
IRENE JAWORSKI
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
08/28/2002
Decision Date
11/21/2002
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
N
Expedited Review
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