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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 K040385
Device Name MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
Applicant
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Applicant Contact KATHRYN J THOMPSON
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact JEREMI PECK
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/17/2004
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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