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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K942353
Device Name CENTURION UMBILICAL CATHETER
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 Number880.5200
Classification Product Code
FOS  
Date Received05/17/1994
Decision Date 08/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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