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FDA 510(k) Application Details - K954955
Device Classification Name
Transducer, Pressure, Intrauterine
More FDA Info for this Device
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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More FDA Info for this Product Code
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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