Ultrasonic Surgical Aspirator System

Instrument, Ultrasonic Surgical

SMTP Technology Co., Ltd

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

Pre-market Notification Details

Device IDK202299
510k NumberK202299
Device Name:Ultrasonic Surgical Aspirator System
ClassificationInstrument, Ultrasonic Surgical
Applicant SMTP Technology Co., Ltd 1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang,  CN 215634
ContactSongtao Zhan
CorrespondentRandy Jiang
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-13
Decision Date2021-05-21

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