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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 N.W. 107TH AVE.
MIAMI,  FL  33172
Applicant Contact JESSICA OSWALD-MCLEOD
Correspondent
NIPRO MEDICAL CORPORATION
3150 N.W. 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
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