VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
FDA 510(k) clearance K110958 · decided 2011-08-01
Clearance details
- K-number
- K110958
- Device name
- VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-05
- Decision date
- 2011-08-01
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- FQH
- Device class
- 2
- Regulation number
- 880.5475
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St Petersburg, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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