FDA 510(k) Application Details - K954955

Device Classification Name Transducer, Pressure, Intrauterine

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510(K) Number K954955
Device Name Transducer, Pressure, Intrauterine
Applicant CLINICAL INNOVATIONS, INC.
6477 SOUTH COTTONWOOD ST.
MURRAY, UT 84107 US
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Contact WM. DEAN WALLACE
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Regulation Number 884.2700

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Classification Product Code HFN
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Date Received 10/27/1995
Decision Date 04/17/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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