The following data is part of a premarket notification filed by Enzysurge, Ltd. with the FDA for Silverstream And Dermasept.
| Device ID | K093227 |
| 510k Number | K093227 |
| Device Name: | SILVERSTREAM AND DERMASEPT |
| Classification | Dressing, Wound, Drug |
| Applicant | ENZYSURGE, LTD. 7 JABOTINSKY ST Tel Aviv, IL 52520 |
| Contact | Keren Shtiegman |
| Correspondent | Keren Shtiegman ENZYSURGE, LTD. 7 JABOTINSKY ST Tel Aviv, IL 52520 |
| 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 | 2009-10-14 |
| Decision Date | 2009-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290016506086 | K093227 | 000 |
| 27290016506079 | K093227 | 000 |
| 17290016506065 | K093227 | 000 |