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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 K212677
Device Name aboNT SYRINGE
Applicant
Nipro Medical Corporation
3150 NW 107th Ave.
Miami,  FL  33172
Applicant Contact Jessica Oswald-McLeod
Correspondent
Nipro Medical Corporation
3150 NW 107th Ave.
Miami,  FL  33172
Correspondent Contact Jessica Oswald-McLeod
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received08/24/2021
Decision Date 04/15/2022
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
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