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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 K032854
Device Name UNOMEDICAL MONICA INFUSION SET
Applicant
Unomedical A/S
Aaholmvej 1-3, Osted
Roskilde,  DK DK-4000
Applicant Contact JOHN M LINDSKOG
Correspondent
Unomedical A/S
Aaholmvej 1-3, Osted
Roskilde,  DK DK-4000
Correspondent Contact JOHN M LINDSKOG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/12/2003
Decision Date 10/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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