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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K896320
Device Name CENTURION KLEEN-NEEDLE SYSTEM
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 Number880.5570
Classification Product Code
FMI  
Date Received11/01/1989
Decision Date 01/11/1990
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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