HENKE SASS WOLF OF AMERICA ARTHROSCOPE
FDA 510(k) clearance K080560 · decided 2008-03-18
Clearance details
- K-number
- K080560
- Device name
- HENKE SASS WOLF OF AMERICA ARTHROSCOPE
- Applicant
- Henke Sass Wolf of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-28
- Decision date
- 2008-03-18
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mount Dora, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.