510(k) K842461
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1984
- Date Received
- June 22, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Depressor, Tongue, Non-Surgical
- Device Class
- Class I
- Regulation Number
- 880.6230
- Review Panel
- HO
- Submission Type