Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
FDA 510(k) clearance K210925 · decided 2021-04-28
Clearance details
- K-number
- K210925
- Device name
- Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2021-03-29
- Decision date
- 2021-04-28
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlborough, MA, US
- Third-party review
- Yes
- Expedited review
- No
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