510(k) K936255
Clearance Details
- Decision
- SN ()
- Decision Date
- March 31, 1994
- Date Received
- December 30, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Surgical Instrument, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type