ARTHROSCOPIC SURGICAL BLADE
FDA 510(k) clearance K904284 · decided 1990-12-05
Clearance details
- K-number
- K904284
- Device name
- ARTHROSCOPIC SURGICAL BLADE
- Applicant
- Smith & Nephew Dyonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-17
- Decision date
- 1990-12-05
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.