The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Renasys Ab Abominal Dressing Kit.
| Device ID | K112784 |
| 510k Number | K112784 |
| Device Name: | RENASYS AB ABOMINAL DRESSING KIT |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St. Petersburg, FL 33716 |
| Contact | Laura D Reynolds |
| Correspondent | Laura D Reynolds SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St. Petersburg, FL 33716 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2011-11-22 |
| Summary: | summary |