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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K842176
Device Name RAAF DUAL LUMEN CATHETER
Applicant
QUINTON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
QUINTON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/08/1984
Decision Date 07/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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