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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number BK170033
Tradenames DUO Set, DUO Set A, DUPLOCATH Application Catheter, DUPLOJECT
Device Name Syringe, piston
Original Applicant
Baxter Healthcare Corporation
32650 north wilson rd
round lake,  IL  60073
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/04/2017
Decision Date 07/24/2017
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
In Vitro Product No
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