510(k) K871406

THE WOOG ORABRUSH by Woog Intl. — Product Code JEQ

K871406 is an FDA 510(k) premarket notification submitted by Woog Intl. for the device "THE WOOG ORABRUSH". The FDA issued a decision of Substantially Equivalent on July 7, 1987. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Woog Intl. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1987
Date Received
April 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Toothbrush, Powered
Device Class
Class I
Regulation Number
872.6865
Review Panel
DE
Submission Type