CAST SHOE, CAST BOOT
FDA 510(k) clearance K830246 · decided 1983-02-18
Clearance details
- K-number
- K830246
- Device name
- CAST SHOE, CAST BOOT
- Applicant
- Warm & Form, Orthopedic Materials
- Decision
- Substantially Equivalent
- Date received
- 1983-01-25
- Decision date
- 1983-02-18
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JQB
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.