The following data is part of a premarket notification filed by Zhejiang Longterm Medical Technology Co., Ltd with the FDA for Innomed Npwt Silicone Foam Dressing.
| Device ID | K202823 |
| 510k Number | K202823 |
| Device Name: | Innomed NPWT Silicone Foam Dressing |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Zhejiang Longterm Medical Technology Co., LTD No. 493 North Huancheng Road, Mogan Mountain National High-Tech District Deqing, CN 313200 |
| Contact | Chloie Zsang |
| Correspondent | Claudia Zsang Zhejiang Longterm Medical Technology Co., LTD No. 493 North Huancheng Road, Mogan Mountain National High-Tech District Deqing, CN 313200 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-24 |
| Decision Date | 2021-12-15 |