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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 K122416
Models LGC, LGC/LR, LLC,LLC/LR, LMC, LMC/LR
Device Name ARTIGLASS L. O.R. GLASS SYRINGE
Original Applicant
ARTIGLASS SRL
via piemonte 13
due carrare padova,  IT 35020
Original Contact federico baccarin
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/08/2012
Decision Date 05/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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