BOVIE BUTTON REMOTE HAND SWITCH
FDA 510(k) clearance K060117 · decided 2006-02-22
Clearance details
- K-number
- K060117
- Device name
- BOVIE BUTTON REMOTE HAND SWITCH
- Applicant
- Aaron Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 2006-01-17
- Decision date
- 2006-02-22
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Petersburg, FL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.