The following data is part of a premarket notification filed by Jiangsu Excellence Medical Supplies Co., Ltd with the FDA for Antibacterial Bandage.
| Device ID | K201324 |
| 510k Number | K201324 |
| Device Name: | Antibacterial Bandage |
| Classification | Dressing, Wound, Drug |
| Applicant | Jiangsu Excellence Medical Supplies Co., Ltd No.65 Huiling West Road, Zouqu Town, Zhonglou District Changzhou, CN 203144 |
| Contact | Yanhua Li |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| 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 | 2020-05-18 |
| Decision Date | 2021-02-05 |