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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 K151079
Device Name Q2 Intravenous Adminstration Sets and Extension Sets
Applicant
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Applicant Contact AMY CLENDENING-WHEELER
Correspondent
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Correspondent Contact AMY CLENDENING-WHEELER
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received04/22/2015
Decision Date 09/30/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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