The following data is part of a premarket notification filed by Euromed, Inc. with the FDA for Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin.
| Device ID | K983249 |
| 510k Number | K983249 |
| Device Name: | SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | EUROMED, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane EUROMED, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-16 |
| Decision Date | 1998-11-25 |
| Summary: | summary |