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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K892450
Device Name MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
Applicant
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Applicant Contact RON R DUCK
Correspondent
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Correspondent Contact RON R DUCK
Regulation Number880.5240
Classification Product Code
KGX  
Date Received04/10/1989
Decision Date 10/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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