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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 K122373
Device Name NEOMED ORAL/ENTERAL SYRINGE
Applicant
NEOMED, INC.
100 londonderry ct
suite 112
woodstock,  GA  30188
Applicant Contact melinda harrison
Correspondent
NEOMED, INC.
100 londonderry ct
suite 112
woodstock,  GA  30188
Correspodent Contact melinda harrison
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/06/2012
Decision Date 09/20/2012
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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