510(k) K861142
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- July 10, 1986
- Date Received
- March 26, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type