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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 K100916
Device Name MEDICON MOGEN CLAMP
Applicant
Medicon EG
Gansacker 15
Tuttlingen,  DE D-78532
Applicant Contact JOACHIM SCHMID
Correspondent
Medicon EG
Gansacker 15
Tuttlingen,  DE D-78532
Correspondent Contact JOACHIM SCHMID
Regulation Number884.4530
Classification Product Code
HFX  
Date Received04/02/2010
Decision Date 12/06/2010
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
Predetermined Change
Control Plan Authorized		 No
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