CTD MARK I TRACTION DEVICE
FDA 510(k) clearance K991931 · decided 1999-08-12
Clearance details
- K-number
- K991931
- Device name
- CTD MARK I TRACTION DEVICE
- Applicant
- Therasys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-08
- Decision date
- 1999-08-12
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- ITH
- Device class
- 2
- Regulation number
- 890.5900
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Moraine, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.