510(k) K823372
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1982
- Date Received
- November 12, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Traction, Non-Powered
- Device Class
- Class I
- Regulation Number
- 888.5850
- Review Panel
- NE
- Submission Type