510(k) K092494
K092494 is an FDA 510(k) premarket notification submitted by Luv N' Care, Ltd. for the device "GEL FILLED GUM SOOTHER". The FDA issued a decision of Substantially Equivalent on Mar 1, 2010. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Luv N' Care, Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 2010
- Date Received
- Aug 14, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Ring, Teething, Fluid-Filled
- Device Class
- Class II
- Regulation Number
- 872.5550
- Review Panel
- DE
- Submission Type
- 510(k) Exempt