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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 K190996
Device Name Bonus Therapeutics Mixing and Delivery System
Applicant
Bonus Therapeutics Ltd.
Matam Advanced Technology Park, Building 8B
Haifa,  IL 3190501
Applicant Contact Nir Shtayer
Correspondent
Bonus Therapeutics Ltd.
Matam Advanced Technology Park, Building 8B
Haifa,  IL 3190501
Correspondent Contact Nir Shtayer
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/16/2019
Decision Date 07/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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