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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 K070430
Device Name PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS
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 Received02/13/2007
Decision Date 04/04/2007
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
Predetermined Change
Control Plan Authorized		 No
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