FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
K Number: K110958
·
Decision Aug 1, 2011
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
529
Review Days
118
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Basic Information
- Device Name
- VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
- K Number
- K110958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- April 5, 2011
- Decision Date
- August 1, 2011
- Product Code
- FQH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
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