The following data is part of a premarket notification filed by Island Dressing, Llc. with the FDA for Island Wound Dressing With Microban.
| Device ID | K010951 |
| 510k Number | K010951 |
| Device Name: | ISLAND WOUND DRESSING WITH MICROBAN |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | ISLAND DRESSING, LLC. 300 CORPORATE PKWY. SUITE 116N Amherst, NY 14226 |
| Contact | John A Dobos |
| Correspondent | John A Dobos ISLAND DRESSING, LLC. 300 CORPORATE PKWY. SUITE 116N Amherst, NY 14226 |
| 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 | 2001-03-28 |
| Decision Date | 2001-06-11 |