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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 K132177
Device Name MEDCOMP GEN III POWER INJECTABLE PORT
Applicant
MEDCOMP (MEDICAL COMPONENTS)
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Applicant Contact SARAH SHAFFER
Correspondent
MEDCOMP (MEDICAL COMPONENTS)
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Correspondent Contact SARAH SHAFFER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/15/2013
Decision Date 12/12/2013
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
Recalls CDRH Recalls
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