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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K061539
Device Name GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
Applicant
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84123
Applicant Contact WM DEAN WALLACE
Correspondent
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84123
Correspondent Contact WM DEAN WALLACE
Regulation Number884.4530
Classification Product Code
HFX  
Date Received06/05/2006
Decision Date 09/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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