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

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