FDA 510(k) Application Details - K992305

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K992305
Device Name Transducer, Ultrasonic, Diagnostic
Applicant MEDI-STIM A/S
PO BOX 35 GREFSEN,N-0409 OSLO
SANDAKERVEIEN 110
OSLO N-0475 NO
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Contact JON H HOEM
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 07/08/1999
Decision Date 09/08/1999
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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