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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 K993848
Device Name MILLENNIUM HUBER PLUS SAFETY INFUSION SET
Applicant
MILLENNIUM MEDICAL DISTRIBUTION, INC.
1205 DE LA VINA
SANTA BARBARA,  CA  93101
Applicant Contact CHRISTINE EMANUEL
Correspondent
MILLENNIUM MEDICAL DISTRIBUTION, INC.
1205 DE LA VINA
SANTA BARBARA,  CA  93101
Correspondent Contact CHRISTINE EMANUEL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/12/1999
Decision Date 01/27/2000
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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