FDA 510(k) Application Details - K962293

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K962293
Device Name Transducer, Ultrasonic, Diagnostic
Applicant ENDOSONICS CORP.
3078-B PROSPECT PARK DR.
RANCHO CORDOVA, CA 95670 US
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Contact ADAM D SAVAKUS
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 06/14/1996
Decision Date 09/16/1996
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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