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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 K011071
FOIA Releasable 510(k) K011071
Device Name PARADIGM QUICK-SET INFUSION SET
Applicant
MAERSK MEDICAL A/S
18000 DEVONSHIRE ST.
NORTHRIDGE,  CA  91325 -1219
Applicant Contact GERDA RESCH
Correspondent
MAERSK MEDICAL A/S
18000 DEVONSHIRE ST.
NORTHRIDGE,  CA  91325 -1219
Correspondent Contact GERDA RESCH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/09/2001
Decision Date 06/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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