Cordless Prophy System, Model: I-Polish

Handpiece, Direct Drive, Ac-powered

Guilin Woodpecker Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Cordless Prophy System, Model: I-polish.

Pre-market Notification Details

Device IDK211531
510k NumberK211531
Device Name:Cordless Prophy System, Model: I-Polish
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin,  CN 541004
ContactNing Jiakang
CorrespondentYoyo Chen
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen,  CN 518100
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-17
Decision Date2021-12-17

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