510(k) K760047
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1977
- Date Received
- June 15, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Irrigation, Sterile
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- SU
- Submission Type