POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)

Port & Catheter, Implanted, Subcutaneous, Intravascular

MEDCOMP

The following data is part of a premarket notification filed by Medcomp with the FDA for Power Injectable Implantable Infusion Port With Silicone Lumen (attachable And Pre-attached).

Pre-market Notification Details

Device IDK070003
510k NumberK070003
Device Name:POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant MEDCOMP 1499 DELP DR. Harleysville,  PA  19438
ContactJean Callow
CorrespondentJean Callow
MEDCOMP 1499 DELP DR. Harleysville,  PA  19438
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-03
Decision Date2007-05-15
Summary:summary

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