Single Use Micro Electrode (Brass With Gold Plated Shaft); Single Use Micro Electrode (Stainless Steel Shaft)

Electrosurgical, Cutting & Coagulation & Accessories

Modern Medical Equipment Manufacturing Limited

The following data is part of a premarket notification filed by Modern Medical Equipment Manufacturing Limited with the FDA for Single Use Micro Electrode (brass With Gold Plated Shaft); Single Use Micro Electrode (stainless Steel Shaft).

Pre-market Notification Details

Device IDK163442
510k NumberK163442
Device Name:Single Use Micro Electrode (Brass With Gold Plated Shaft); Single Use Micro Electrode (Stainless Steel Shaft)
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Modern Medical Equipment Manufacturing Limited 35-41 Tai Lin Pai Rd, Unit F 5th Fl, Gold King Ind., Bldg., Kwai Chung, N.T. Hong Kong,  CN
ContactThomas Tsz Fung Chan
CorrespondentSamson Woo
Modern Medical Equipment Manufacturing Limited 35-41 Tai Lin Pai Rd, Unit F 5th Fl, Gold King Ind., Bldg., Kwai Chung, N.T. Hong Kong,  CN
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-08
Decision Date2017-09-28
Summary:summary

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