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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K222852
Device Name Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
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-McLeaod
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FMF  
Date Received09/21/2022
Decision Date 05/25/2023
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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