510(k) K942967
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1994
- Date Received
- June 20, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Non-Powered
- Device Class
- Class I
- Regulation Number
- 882.4535
- Review Panel
- NE
- Submission Type