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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 K013871
Device Name LIFEGUARD SAFETY INFUSION SET
Original Applicant
HORIZON MEDICAL PRODUCTS, INC.
1 horizon way
manchester,  GA  31816
Original Contact patricia d jones
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/21/2001
Decision Date 03/29/2002
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
Recalls CDRH Recalls
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