LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8

Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

LINA MEDICAL APS

The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Loop, Models: El-160-4, El-160-8, El-200-4, El-200-8.

Pre-market Notification Details

Device IDK070315
510k NumberK070315
Device Name:LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
ClassificationCoagulator-cutter, Endoscopic, Unipolar (and Accessories)
Applicant LINA MEDICAL APS 1289 N. FORDHAM BLVD. SUITE A-128 Chapel Hill,  NC  27517
ContactWalt Brittle
CorrespondentWalt Brittle
LINA MEDICAL APS 1289 N. FORDHAM BLVD. SUITE A-128 Chapel Hill,  NC  27517
Product CodeKNF  
CFR Regulation Number884.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-01
Decision Date2007-10-30
Summary:summary

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