510(k) K821127
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1982
- Date Received
- April 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bit, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type