The following data is part of a premarket notification filed by Zhejiang Longterm Medical Technology Co., Ltd. with the FDA for Lt Antibacterial Alginate With Silver Dressing.
| Device ID | K192478 |
| 510k Number | K192478 |
| Device Name: | LT Antibacterial Alginate With Silver Dressing |
| Classification | Dressing, Wound, Drug |
| 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 Zhenjiang Longterm Medical Technology Co., Ltd. No. 493 North Huancheng Road, Morgan Mountain National High- Tech District Deqing, CN 313200 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-09-10 |
| Decision Date | 2020-06-17 |