REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
FDA 510(k) clearance K012611 · decided 2001-11-07
Clearance details
- K-number
- K012611
- Device name
- REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
- Applicant
- Alliance Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2001-11-07
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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