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.
| Device ID | K202898 |
| 510k Number | K202898 |
| Device Name: | Tzoar 207 Negative Pressure Wound Therapy (NPWT) System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Lightstone Medical Products (Ningbo) Co Ltd Room 61-408, No. 99 Jiangbei Road Ningbo, CN 315032 |
| Contact | Julian Zhu |
| Correspondent | Ruth Wu Lightstone Medical 1820 Ave M, Ste 238 Brookyln, NY 11230 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 |