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FDA 510(k) Application Details - K061539
Device Classification Name
Clamp, Circumcision
More FDA Info for this Device
510(K) Number
K061539
Device Name
Clamp, Circumcision
Applicant
CLINICAL INNOVATIONS, LLC
747 WEST 4170 SOUTH
MURRAY, UT 84123 US
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Contact
WM DEAN WALLACE
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Regulation Number
884.4530
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Classification Product Code
HFX
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More FDA Info for this Product Code
Date Received
06/05/2006
Decision Date
09/20/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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