LIGAMAX 5

Clip, Implantable

ETHICON ENDO-SUGERY, LLC

The following data is part of a premarket notification filed by Ethicon Endo-sugery, Llc with the FDA for Ligamax 5.

Pre-market Notification Details

Device IDK110699
510k NumberK110699
Device Name:LIGAMAX 5
ClassificationClip, Implantable
Applicant ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. Cincinnati,  OH  45242
ContactEmily Kruetzkamp
CorrespondentEmily Kruetzkamp
ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. Cincinnati,  OH  45242
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-14
Decision Date2011-03-25
Summary:summary

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