510(k) K780891
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1978
- Date Received
- May 31, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Joint, Hip, External Brace
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type