New Deantronics Disposable Laparoscopic Electrodes, Non-coated, And Coated

Electrosurgical, Cutting & Coagulation & Accessories

New Deantronics Taiwan, Ltd.

The following data is part of a premarket notification filed by New Deantronics Taiwan, Ltd. with the FDA for New Deantronics Disposable Laparoscopic Electrodes, Non-coated, And Coated.

Pre-market Notification Details

Device IDK153265
510k NumberK153265
Device Name:New Deantronics Disposable Laparoscopic Electrodes, Non-coated, And Coated
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant New Deantronics Taiwan, Ltd. 12F, No. 51, Sec. 4, Chong Yang Road, Tu Cheng Dist. New Taipei City,  TW 23675
ContactJane Liu
CorrespondentLewis Ward
L.W. Ward And Associates, Inc. 4655 Kirkwood Court Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-12
Decision Date2016-01-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521550824 K153265 000
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20884521549019 K153265 000
20884521549026 K153265 000
20884521549033 K153265 000
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20884521549057 K153265 000
20884521550763 K153265 000
20884521550770 K153265 000
20884521550787 K153265 000
20884521550794 K153265 000
20884521550817 K153265 000
20884521550831 K153265 000
20884521548982 K153265 000
20884521550800 K153265 000
20884521548999 K153265 000

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