The following data is part of a premarket notification filed by Jiangsu Newvalue Medical Producst Co.,ltd with the FDA for Surecell Gelling Fiber Wound Dressing.
| Device ID | K173005 |
| 510k Number | K173005 |
| Device Name: | SURECELL Gelling Fiber Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Jiangsu Newvalue Medical Producst Co.,Ltd Building G35.the East Of KouTai Road And The North Of Xin Yang Road.CMC. Taizhou, CN 225300 |
| Contact | Julie Chen |
| Correspondent | Julie Chen Jiangsu Newvalue Medical Producst Co.,Ltd Building G35.the East Of KouTai Road And The North Of Xin Yang Road.CMC. Taizhou, CN 225300 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-05-25 |
| Summary: | summary |