510(k) K852726
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1985
- Date Received
- June 26, 1985
- 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