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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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