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FDA 510(k) Application Details - K030691
Device Classification Name
Electrode, Circular (Spiral), Scalp And Applicator
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
884.2675
More FDA Info for this Regulation Number
Classification Product Code
HGP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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