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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intrauterine
510(k) Number K961290
Device Name IUP - TIP TRANS, IUP - PROXI TRANS
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 Number884.2700
Classification Product Code
KXO  
Date Received04/04/1996
Decision Date 10/15/1996
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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