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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K971928
Device Name QUEST VESSEL CATHETER
Applicant
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Applicant Contact KRISTA OAKES
Correspondent
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Correspondent Contact KRISTA OAKES
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/27/1997
Decision Date 11/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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