The following data is part of a premarket notification filed by Zhejiang Longterm Medical Technology Co., Ltd with the FDA for Longterm Npwt Foam Dressing Kit.
| Device ID | K182458 |
| 510k Number | K182458 |
| Device Name: | Longterm NPWT Foam Dressing Kit |
| 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 | Claudia 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 | 2018-09-10 |
| Decision Date | 2019-05-23 |