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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K871749
Device Name ADULT PERM-CATH 40CM.
Applicant
QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021 -8906
Applicant Contact RANDY WALLS
Correspondent
QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021 -8906
Correspondent Contact RANDY WALLS
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received05/05/1987
Decision Date 06/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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