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FDA 510(k) Application Details - K973746
Device Classification Name
Transducer, Pressure, Intrauterine
More FDA Info for this Device
510(K) Number
K973746
Device Name
Transducer, Pressure, Intrauterine
Applicant
CLINICAL INNOVATIONS, INC.
6477 SOUTH COTTONWOOD ST.
MURRAY, UT 84107 US
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Contact
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
10/01/1997
Decision Date
11/24/1997
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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