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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fibrin sealant preparation device
510(k) Number BK190324
Tradenames VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) , VISTASEAL™ Laparoscopic Dual Applicator (35 em Rigid or 45 em Flexible)
Device Name Fibrin Sealant Preparation Device
Original Applicant
route 22 west
p.o. box 151
somerville,  NJ  08876 US
Regulation Number880.5860
Classification Product Code
Date Received02/28/2019
Decision Date 06/05/2019
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee Hematology
Type 510(k) Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No