The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Versajet Ii Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet Footswitch.
| Device ID | K110958 |
| 510k Number | K110958 |
| Device Name: | VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH |
| Classification | Lavage, Jet |
| Applicant | SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. SUITE 110 St. Petersburg, FL 33716 |
| Contact | Laura Reynolds |
| Correspondent | Laura Reynolds SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. SUITE 110 St. Petersburg, FL 33716 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-05 |
| Decision Date | 2011-08-01 |
| Summary: | summary |