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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 K202672
Device Name Precision Delivery Infusion Set
Applicant
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Applicant Contact Tosan Eweka
Correspondent
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Correspondent Contact Tosan Eweka
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/15/2020
Decision Date 01/21/2021
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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