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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 K073210
Device Name MODIFICATION TO: T-PORT HP INFUSION PORT
Applicant
PFM MEDICAL, INC
2605 TEMPLE HEIGHTS DRIVE
SUITE A
OCEANSIDE,  CA  92056
Applicant Contact SALVADORE PALOMARES
Correspondent
PFM MEDICAL, INC
2605 TEMPLE HEIGHTS DRIVE
SUITE A
OCEANSIDE,  CA  92056
Correspondent Contact SALVADORE PALOMARES
Regulation Number880.5965
Classification Product Code
LJT  
Date Received11/14/2007
Decision Date 12/12/2007
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
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