MAM COOLER
Device Facts
| Record ID | K093266 |
|---|---|
| Device Name | MAM COOLER |
| Applicant | Mam International AG |
| Product Code | KKO · Dental |
| Decision Date | Jul 27, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5550 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.
Special Controls
*Classification.* Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
