510(k) K820351
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1982
- Date Received
- February 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Cast Removal, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 888.5960
- Review Panel
- OR
- Submission Type