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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 K130002
Device Name SURECALL LABOR MONITOR
Applicant
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
1770 ST. JAMES, STE 600
HOUSTON,  TX  77056 -3433
Applicant Contact J. HARVEY KNAUSS
Correspondent
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
1770 ST. JAMES, STE 600
HOUSTON,  TX  77056 -3433
Correspondent Contact J. HARVEY KNAUSS
Regulation Number884.2720
Classification Product Code
OSP  
Date Received01/02/2013
Decision Date 06/28/2013
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
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