510(k) K843406
K843406 is an FDA 510(k) premarket notification submitted by Senair-Mot for the device "CHEW-DENT". The FDA issued a decision of Substantially Equivalent on December 11, 1984. The device falls under product code JEW (Tip, Rubber, Oral Hygiene), a Class I device regulated under 21 CFR 872.6650. Senair-Mot has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1984
- Date Received
- August 31, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tip, Rubber, Oral Hygiene
- Device Class
- Class I
- Regulation Number
- 872.6650
- Review Panel
- DE
- Submission Type