ASCOT
FDA 510(k) clearance K132310 · decided 2013-12-23
Clearance details
- K-number
- K132310
- Device name
- ASCOT
- Applicant
- Backroads Consulting, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-25
- Decision date
- 2013-12-23
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Chesterland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.