The following data is part of a premarket notification filed by Euromed, Inc. with the FDA for Sureskin Silver Bandages.
| Device ID | K081274 |
| 510k Number | K081274 |
| Device Name: | SURESKIN SILVER BANDAGES |
| Classification | Dressing, Wound, Drug |
| Applicant | EUROMED, INC. 25 CORPORATE DRIVE Orangeburg, NY 10962 |
| Contact | Subhash Chander |
| Correspondent | Subhash Chander EUROMED, INC. 25 CORPORATE DRIVE Orangeburg, NY 10962 |
| 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 | 2008-05-05 |
| Decision Date | 2008-05-28 |
| Summary: | summary |