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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 K935491
Device Name CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)
Applicant
Tri-State Hospital Supply Corp.
301 Catrell Dr.
Howell,  MI  48843
Applicant Contact GEORGE J PLUTA
Correspondent
Tri-State Hospital Supply Corp.
301 Catrell Dr.
Howell,  MI  48843
Correspondent Contact GEORGE J PLUTA
Regulation Number884.4530
Classification Product Code
HFX  
Date Received11/15/1993
Decision Date 02/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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