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FDA 510(k) Application Details - K962093
Device Classification Name
Transducer, Ultrasonic, Diagnostic
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510(K) Number
K962093
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
SONOTECH, INC.
1413 FRASER ST.
BUILDING H, SUITE 102
BELLINGHAM, WA 98226 US
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Contact
MARGARET J LARSON
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Regulation Number
892.1570
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Classification Product Code
ITX
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More FDA Info for this Product Code
Date Received
05/29/1996
Decision Date
12/23/1996
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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