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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 K120281
Device Name DIGNITY POWER INJECTABLE TITANIUM PORT
Original Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Original Contact rosanna severini
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/31/2012
Decision Date 09/17/2012
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
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