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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K101180
Model 21-3253-24, 21-3258-24, 21-3262-24, 21-3273-24, 21-3278-24, 21-3282-24
Device Name GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,
Original Applicant
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact saint paul
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/27/2010
Decision Date 08/03/2010
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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