510(k) K841323
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 1984
- Date Received
- April 2, 1984
- 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