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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 K153238
Device Name Dignity Dual Port
Applicant
Medcomp ( Medical Components)
1499 Delp Drive
Harleysville,  PA  19438
Applicant Contact Beth Ann Giammaruti
Correspondent
Medcomp ( Medical Components)
1499 Delp Drive
Harleysville,  PA  19438
Correspondent Contact Courtney Nix
Regulation Number880.5965
Classification Product Code
LJT  
Date Received11/09/2015
Decision Date 03/15/2016
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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