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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Circular (Spiral), Scalp And Applicator
510(k) Number K904745
Device Name MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE
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 Number884.2675
Classification Product Code
HGP  
Date Received10/18/1990
Decision Date 01/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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