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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter,intravascular,therapeutic,short-term less than 30 days
510(k) Number K121007
Model 3778522, 3779422, 3769522, 3768522, 3788522, 3748522, 3749522, 3738522, 3728522, 3718522, 3778122, 3779122, 3768122, 376
Device Name NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
Original Applicant
DELTA MED SRL
721 kristin court
westmont,  IL  60559
Original Contact harry bontrager
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/03/2012
Decision Date 12/28/2012
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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