510(k) K833485
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 1983
- Date Received
- October 7, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Impression, Preformed
- Device Class
- Class I
- Regulation Number
- 872.6880
- Review Panel
- DE
- Submission Type