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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Uterine Contraction, External (For Use In Clinic)
510(k) Number K952579
Device Name TOCO TRANSDUCER
Applicant
Scientific Device Manufacturer, LLC
999 Andersen Dr., Suite 120
San Rafael,  CA  94901
Applicant Contact RICHARD C BALL
Correspondent
Scientific Device Manufacturer, LLC
999 Andersen Dr., Suite 120
San Rafael,  CA  94901
Correspondent Contact RICHARD C BALL
Regulation Number884.2720
Classification Product Code
HFM  
Date Received06/05/1995
Decision Date 08/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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