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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 K130049
Device Name MONOJECT 12ML 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  
Date Received01/08/2013
Decision Date 02/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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