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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 K894650
Device Name Q-PORT SYSTEM KIT
Applicant
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact RON DUCK
Correspondent
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact RON DUCK
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/24/1989
Decision Date 03/12/1990
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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