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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K840815
Device Name LUER LOCKING ADAPTER(MATERIAL CHANGE)
Applicant
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact DAN ROPER
Correspondent
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact DAN ROPER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/27/1984
Decision Date 11/08/1984
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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