The following data is part of a premarket notification filed by Solaplus Biotech Co., Ltd. with the FDA for Hemostatic Xerogel Sponge.
| Device ID | K192671 |
| 510k Number | K192671 |
| Device Name: | Hemostatic Xerogel Sponge |
| Classification | Dressing, Wound, Drug |
| Applicant | Solaplus Biotech Co., Ltd. No. 75 Feng Fang Road, Ouhai Economic Development Zone Wenzhou, CN 325014 |
| Contact | Xiangui Shen |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai 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 | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-08-28 |