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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
Doral,  FL  33172
Applicant Contact Jessica Oswald-McLeod
Correspondent
Nipro Medical Corporation
3150 NW 107th Ave
Doral,  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
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