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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 K113673
Device Name MYSAFETY SYRINGE
Original Applicant
MEDICALCHAIN INTERNARTIONAL CORPORATION
1808 seabreeze court
thousand oaks,  CA  91320
Original Contact robin hwang
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MEG  
Date Received12/13/2011
Decision Date 08/03/2012
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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