ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC

Electrosurgical, Cutting & Coagulation & Accessories

E SURGICAL, LLC

The following data is part of a premarket notification filed by E Surgical, Llc with the FDA for Electrode Coated Ball, Model Ab302c; Needle, Model An301c; Blade, Model Ae301hc.

Pre-market Notification Details

Device IDK061878
510k NumberK061878
Device Name:ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant E SURGICAL, LLC 4655 KIRKWOOD COURT Boulder,  CO  80301
ContactLewis Ward
CorrespondentLewis Ward
E SURGICAL, LLC 4655 KIRKWOOD COURT Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-03
Decision Date2006-10-24
Summary:summary

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