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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K091099
Device Name C-PORT - HP POWER INJECTABLE PORT
Applicant
Phs Medical GmbH
2360 Johnson Rd.
Southlake,  TX  76092
Applicant Contact DONALD F HULTS
Correspondent
Phs Medical GmbH
2360 Johnson Rd.
Southlake,  TX  76092
Correspondent Contact DONALD F HULTS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received04/16/2009
Decision Date 05/22/2009
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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