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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 K030691
Device Name FETAL SPIRAL ELECTRODE, MODEL FSE07000
Applicant
CLINICAL INNOVATIONS, INC.
747 WEST 4170 SOUTH
MURRAY,  UT  84123
Applicant Contact WILLIAM DEAN WALLACE
Correspondent
CLINICAL INNOVATIONS, INC.
747 WEST 4170 SOUTH
MURRAY,  UT  84123
Correspondent Contact WILLIAM DEAN WALLACE
Regulation Number884.2675
Classification Product Code
HGP  
Date Received03/05/2003
Decision Date 09/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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