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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 Dr.
Harleysville,  PA  19438
Applicant Contact Beth Ann Giammaruti
Correspondent
Medcomp ( Medical Components)
1499 Delp Dr.
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
Predetermined Change
Control Plan Authorized		 No
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