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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Intrauterine
510(k) Number K954955
Device Name STORC INTRAUTERINE PRESSURE CATHETER
Applicant
CLINICAL INNOVATIONS, INC.
6477 SOUTH COTTONWOOD ST.
MURRAY,  UT  84107
Applicant Contact WM. DEAN WALLACE
Correspondent
CLINICAL INNOVATIONS, INC.
6477 SOUTH COTTONWOOD ST.
MURRAY,  UT  84107
Correspondent Contact WM. DEAN WALLACE
Regulation Number884.2700
Classification Product Code
HFN  
Date Received10/27/1995
Decision Date 04/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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