FDA 510(k) Application Details - K001203

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K001203
Device Name Transducer, Ultrasonic, Diagnostic
Applicant THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE, NY 11747 US
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Contact LAURA STORMS-TYLER
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 04/13/2000
Decision Date 05/26/2000
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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