510(k) K921546
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- July 2, 1993
- Date Received
- April 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Instruments, G-U, Manual (And Accessories)
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type