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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Set, Administration, Intravascular
510(k) Number K002689
Device Name SWABSITE SWABBABLE VALVE, MODEL 245000
Applicant
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Applicant Contact DOUG BRYAN
Correspondent
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Correspondent Contact DOUG BRYAN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/29/2000
Decision Date 03/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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