The following data is part of a premarket notification filed by Enzysurge Ltd. with the FDA for Silverstream Gel.
| Device ID | K200767 |
| 510k Number | K200767 |
| Device Name: | SilverStream Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | EnzySurge Ltd. 26 Shabazi St. Rosh Ha'ayin, IL 4802126 |
| Contact | Moshe Landsberg |
| Correspondent | Daniel Albahari BioReg Services 6 Beit HaShoeva St. Jerusalem, IL 9751723 |
| 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 | 2020-03-25 |
| Decision Date | 2020-10-08 |