510(k) K941164
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1994
- Date Received
- March 11, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Evacuator, Oral Cavity
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type