MODEL 418 SERIES WALKERS
FDA 510(k) clearance K053192 · decided 2005-12-05
Clearance details
- K-number
- K053192
- Device name
- MODEL 418 SERIES WALKERS
- Applicant
- Mjm International Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-11-15
- Decision date
- 2005-12-05
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- NXE
- Device class
- 1
- Regulation number
- 890.3825
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Juan, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.