5X2 SATALEC CHIROPODY CASE
FDA 510(k) clearance K853200 · decided 1985-10-18
Clearance details
- K-number
- K853200
- Device name
- 5X2 SATALEC CHIROPODY CASE
- Applicant
- Spelna, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-14
- Decision date
- 1985-10-18
- Days to decision
- 126 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Fredericksburg, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.