510(k) K813000
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1982
- Date Received
- October 26, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthopedic Manual Surgical Instrument
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type