Tzoar 207 Negative Pressure Wound Therapy (NPWT) System

Negative Pressure Wound Therapy Powered Suction Pump

Lightstone Medical Products (Ningbo) Co Ltd

The following data is part of a premarket notification filed by Lightstone Medical Products (ningbo) Co Ltd with the FDA for Tzoar 207 Negative Pressure Wound Therapy (npwt) System.

Pre-market Notification Details

Device IDK202898
510k NumberK202898
Device Name:Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Lightstone Medical Products (Ningbo) Co Ltd Room 61-408, No. 99 Jiangbei Road Ningbo,  CN 315032
ContactJulian Zhu
CorrespondentRuth Wu
Lightstone Medical 1820 Ave M, Ste 238 Brookyln,  NY  11230
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-12-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10850017034171 K202898 000
10850017034010 K202898 000
10850017034027 K202898 000
10850017034034 K202898 000
10850017034041 K202898 000
10850017034058 K202898 000
10850017034065 K202898 000
10850017034072 K202898 000
10850017034089 K202898 000
10850017034096 K202898 000
10850017034102 K202898 000
10850017034140 K202898 000
00850017034006 K202898 000

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