The following data is part of a premarket notification filed by Smith & Nephew Wound Management with the FDA for Versajet Hydrosurgery System And Handpiece.
| Device ID | K060782 |
| 510k Number | K060782 |
| Device Name: | VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE |
| Classification | Lavage, Jet |
| Applicant | SMITH & NEPHEW WOUND MANAGEMENT 11775 STARKEY ROAD Largo, FL 33773 |
| Contact | Terry Mcmahon |
| Correspondent | Terry Mcmahon SMITH & NEPHEW WOUND MANAGEMENT 11775 STARKEY ROAD Largo, FL 33773 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-22 |
| Decision Date | 2006-04-12 |
| Summary: | summary |