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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 (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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