OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB

Electrosurgical, Cutting & Coagulation & Accessories

JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO

The following data is part of a premarket notification filed by Jiangmen City Xinhui Baisheng Medical Equipment Co with the FDA for Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models Gbs-dm, Gbs-db.

Pre-market Notification Details

Device IDK102372
510k NumberK102372
Device Name:OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO BUILDING 1, NO.1, HUIMIN EAST RD HUICHENG TOWN, XINHUI DISTR Jiangmen City, Guangdong,  CN 529100
ContactChen Xi
CorrespondentWilliam J Sammons
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-08-20
Decision Date2010-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10850014433168 K102372 000
00817771029013 K102372 000
20885632412902 K102372 000
20885632412896 K102372 000
20885632412889 K102372 000

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