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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 K950498
Device Name LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
Applicant
Graphic Controls Corp.
P.O. Box 1274
189 Van Rensselaer St.
Buffalo,  NY  14240
Applicant Contact IGNATY GUSAKOV
Correspondent
Graphic Controls Corp.
P.O. Box 1274
189 Van Rensselaer St.
Buffalo,  NY  14240
Correspondent Contact IGNATY GUSAKOV
Regulation Number884.2700
Classification Product Code
KXO  
Date Received02/06/1995
Decision Date 07/24/1995
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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