HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY

Instrument, Ultrasonic Surgical

ETHICON ENDO-SURGERY, LLC

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Focus Shears + Adaptive Tissue Technology.

Pre-market Notification Details

Device IDK133314
510k NumberK133314
Device Name:HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
ClassificationInstrument, Ultrasonic Surgical
Applicant ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
ContactBrian Godwin
CorrespondentBrian Godwin
ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-28
Decision Date2013-12-03
Summary:summary

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