Ultrasonic Osteotomy Surgical System

Instrument, Surgical, Sonic And Accessory/attachment

SMTP Technology Co., Ltd

The following data is part of a premarket notification filed by Smtp Technology Co., Ltd with the FDA for Ultrasonic Osteotomy Surgical System.

Pre-market Notification Details

Device IDK201274
510k NumberK201274
Device Name:Ultrasonic Osteotomy Surgical System
ClassificationInstrument, Surgical, Sonic And Accessory/attachment
Applicant SMTP Technology Co., Ltd 1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang,  CN 215634
ContactSongtao Zhan
CorrespondentSongtao Zhan
SMTP Technology Co., Ltd 1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang,  CN 215634
Product CodeJDX  
CFR Regulation Number888.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-12
Decision Date2021-02-19

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