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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 K070003
Device Name POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
Applicant
MEDCOMP
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Applicant Contact JEAN CALLOW
Correspondent
MEDCOMP
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Correspondent Contact JEAN CALLOW
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/03/2007
Decision Date 05/15/2007
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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