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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K120337
Device Name I-PORT ADVANCE INJECTION PORT
Applicant
Unomedical A/S
Aaholmvej 1-3
Osted,  DK 4320
Applicant Contact SOREN MELSTED
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/03/2012
Decision Date 02/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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