510(k) K941066
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1995
- Date Received
- March 8, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Zinc Oxide Eugenol
- Device Class
- Class I
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type