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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, antistick
510(K) Number K121637
Model 5ML
Device Name AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
Applicant
SUNWELL BIOTECH CO., LTD
77325 joyce way
echo,  OR  97826
Contact charlie mack
Regulation Number880.5860
Classification Product Code
MEG  
Date Received06/04/2012
Decision Date 10/25/2012
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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