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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 K021916
Device Name HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
Original Applicant
HARMAC MEDICAL PRODUCTS, INC.
2201 bailey ave.
buffalo,  NY  14211 1797
Original Contact robert f moran
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Codes
FMI   LJT  
Date Received06/11/2002
Decision Date 08/29/2002
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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