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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K964117
Device Name NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
Applicant
Kawasumi Laboratories Co., Ltd.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact DONALD R STONE
Correspondent
Kawasumi Laboratories Co., Ltd.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact DONALD R STONE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received10/15/1996
Decision Date 03/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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