The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew 25 Fluid Management System.
| Device ID | K051326 |
| 510k Number | K051326 |
| Device Name: | SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM |
| Classification | Arthroscope |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-06-15 |
| Summary: | summary |