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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 K122787
Device Name COMFORT EZ
Original Applicant
SIMPLE DIAGNOSTICS, INC.
8870 ravello ct
naples,  FL  34114
Original Contact daniel kamm, p.e.
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/11/2012
Decision Date 12/06/2012
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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