510(k) K864870
K864870 is an FDA 510(k) premarket notification submitted by Levolon Company, Inc. for the device "THUMBSHELPER POWER RING". The FDA issued a decision of Substantially Equivalent on February 12, 1987. The device falls under product code LQX (Device, Finger-Sucking), a Class I device regulated under 21 CFR 890.3475.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1987
- Date Received
- December 12, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Finger-Sucking
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- DE
- Submission Type