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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name uterine electromyographic monitor
510(k) Number K090145
Device Name SURECALL EMG LABOR MONITOR
Applicant
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
11874 SOUTH EVELYN
HOUSTON,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
11874 SOUTH EVELYN
HOUSTON,  TX  77071
Correspondent Contact J. HARVEY KNAUSS
Regulation Number884.2720
Classification Product Code
OSP  
Date Received01/21/2009
Decision Date 01/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01282710
NCT01282723
Reviewed by Third Party No
Combination Product No
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