510(k) K971639
K971639 is an FDA 510(k) premarket notification submitted by Sas Group, Inc. for the device "PLUSTRON ION TOOTHBRUSH SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 1997. The device falls under product code MMD (Toothbrush, Ionic, Battery-Powered), a Class I device regulated under 21 CFR 872.6865.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1997
- Date Received
- May 2, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Toothbrush, Ionic, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 872.6865
- Review Panel
- DE
- Submission Type