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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K910418
Device Name LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100
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 Number884.2740
Classification Product Code
HGM  
Date Received01/30/1991
Decision Date 07/16/1991
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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