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 |