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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 K110424
Device Name DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
Applicant
MEDCOMP (MEDICAL COMPONENTS)
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Applicant Contact JEAN CALLOW
Correspondent
MEDCOMP (MEDICAL COMPONENTS)
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Correspondent Contact JEAN CALLOW
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/14/2011
Decision Date 11/30/2011
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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