PlaDuo System

Electrosurgical, Cutting & Coagulation & Accessories

ShenB Co Ltd

The following data is part of a premarket notification filed by Shenb Co Ltd with the FDA for Pladuo System.

Pre-market Notification Details

Device IDK201735
510k NumberK201735
Device Name:PlaDuo System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ShenB Co Ltd ShenB Bldg 148 Seongsui-ro Seoul,  KR 04796
ContactOskar Lee
CorrespondentConnie Hoy
Hoy And Associates 3916 N. Potsdam Ave #4676 Sioux Falls,  SD  57104
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-25
Decision Date2020-12-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000
08800017100159 K201735 000

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