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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 K191359
Device Name Nipro 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 Received05/21/2019
Decision Date 10/09/2019
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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