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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 K890897
Device Name CENTURION CIRCLAMP
Applicant
Tri-State Hospital Supply Corp.
301 Catrell Dr.
P.O. Box 170
Howell,  MI  48843
Applicant Contact GEORGE J PLUTA
Correspondent
Tri-State Hospital Supply Corp.
301 Catrell Dr.
P.O. Box 170
Howell,  MI  48843
Correspondent Contact GEORGE J PLUTA
Regulation Number884.4530
Classification Product Code
HFX  
Date Received02/22/1989
Decision Date 03/28/1989
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
Recalls CDRH Recalls
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