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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 K943732
Device Name LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
Applicant
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
BUFFALO,  NY  14240
Applicant Contact JOHN H BARRETT
Correspondent
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
BUFFALO,  NY  14240
Correspondent Contact JOHN H BARRETT
Regulation Number884.2675
Classification Product Code
HGP  
Date Received08/02/1994
Decision Date 10/20/1994
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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