The following data is part of a premarket notification filed by Hangzhou Zeo-innov Life Technology Co., Ltd. with the FDA for Zeolite Hemostatic Gauze.
| Device ID | K211570 |
| 510k Number | K211570 |
| Device Name: | Zeolite Hemostatic Gauze |
| Classification | Dressing, Wound, Drug |
| Applicant | Hangzhou Zeo-Innov Life Technology Co., Ltd. R101, Building 2, No.291 Fucheng Road, HEDA Hangzhou, CN 310018 |
| Contact | Lijuan Zhao |
| 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 | No |
| Date Received | 2021-05-21 |
| Decision Date | 2022-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972060310235 | K211570 | 000 |
| 06972060310464 | K211570 | 000 |