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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 BK140119
Tradename RaplixaSpray Device
Device Name Syringe, piston
Original Applicant
ProFibrix BV
darwinweg 24
leiden,  2333 CR
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/14/2014
Decision Date 04/30/2015
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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