510(k) K915576
K915576 is an FDA 510(k) premarket notification submitted by Hukuba Dental Corp. for the device "HUBUKA HYG TOOTHBRUSH". The FDA issued a decision of Substantially Equivalent on March 4, 1994. The device falls under product code MMD (Toothbrush, Ionic, Battery-Powered), a Class I device regulated under 21 CFR 872.6865. Hukuba Dental Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1994
- Date Received
- December 12, 1991
- 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