CT SPACER
FDA 510(k) clearance K010680 · decided 2001-05-23
Clearance details
- K-number
- K010680
- Device name
- CT SPACER
- Applicant
- Clinical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-07
- Decision date
- 2001-05-23
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Barstow, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.