SILKRO

Electrosurgical, Cutting & Coagulation & Accessories

Hironic Co., Ltd

The following data is part of a premarket notification filed by Hironic Co., Ltd with the FDA for Silkro.

Pre-market Notification Details

Device IDK210084
510k NumberK210084
Device Name:SILKRO
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Hironic Co., Ltd 19F, 767, Sinsu-Ro, Suji-Gu Yongin-Si,  KR 16827
ContactJi Yeong Seo
CorrespondentSanghwa Myung
E&M D-1474, 230, Simin-daero, Dongan-gu Anyang,  KR 14067
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-12
Decision Date2022-06-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800016213027 K210084 000

Trademark Results [SILKRO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILKRO
SILKRO
97148122 not registered Live/Pending
HIRONIC CO., LTD.
2021-11-30

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