FDA 510(k) Application Details - K030691

Device Classification Name Electrode, Circular (Spiral), Scalp And Applicator

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510(K) Number K030691
Device Name Electrode, Circular (Spiral), Scalp And Applicator
Applicant CLINICAL INNOVATIONS, INC.
747 WEST 4170 SOUTH
MURRAY, UT 84123 US
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Contact WILLIAM DEAN WALLACE
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Regulation Number 884.2675

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Classification Product Code HGP
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Date Received 03/05/2003
Decision Date 09/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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