510(k) K832741
K832741 is an FDA 510(k) premarket notification submitted by Orthomedics for the device "JASON CERVICAL ORTHOSIS". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code IQF (Orthosis, Cervical-Thoracic, Rigid), a Class I device regulated under 21 CFR 890.3490. Orthomedics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1983
- Date Received
- August 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cervical-Thoracic, Rigid
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type