510(k) K913152
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1991
- Date Received
- July 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown, Preformed
- Device Class
- Class I
- Regulation Number
- 872.3330
- Review Panel
- DE
- Submission Type