Dental Electric Motor

Controller, Foot, Handpiece And Cord

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 Dental Electric Motor.

Pre-market Notification Details

Device IDK203706
510k NumberK203706
Device Name:Dental Electric Motor
ClassificationController, Foot, Handpiece And Cord
Applicant Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin,  CN 541004
ContactJiakang Ning
CorrespondentField Fu
Shenzhen Joyantech Consulting Co., Ltd. Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen,  CN
Product CodeEBW  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-18
Decision Date2022-01-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944843611563 K203706 000
06944843611518 K203706 000
06944843611488 K203706 000
06944843611259 K203706 000
06944843605395 K203706 000
06944843605173 K203706 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.