510(k) K093266
K093266 is an FDA 510(k) premarket notification submitted by Mam International AG for the device "MAM COOLER". The FDA issued a decision of Substantially Equivalent on Jul 27, 2010. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Mam International AG has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 2010
- Date Received
- Oct 19, 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