FDA 510(k) Application Details - K964658

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K964658
Device Name Transducer, Ultrasonic, Diagnostic
Applicant SONOTECH, INC.
774 MARINE DR.
BELLINGHAM, WA 98225 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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Date Received 11/20/1996
Decision Date 02/14/1997
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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