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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 K910282
Device Name MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER
Applicant
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1274
Buffalo,  NY  14240
Applicant Contact VAN DINE
Correspondent
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1274
Buffalo,  NY  14240
Correspondent Contact VAN DINE
Regulation Number884.2720
Classification Product Code
HFM  
Date Received01/23/1991
Decision Date 03/29/1991
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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