The following data is part of a premarket notification filed by Mam International Ag with the FDA for Mam Cooler.
| Device ID | K093266 |
| 510k Number | K093266 |
| Device Name: | MAM COOLER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | MAM INTERNATIONAL AG CORPORATE PARK DRIVE 106 White Plains, NY 10604 |
| Contact | Michael Tedesco |
| Correspondent | Michael Tedesco MAM INTERNATIONAL AG CORPORATE PARK DRIVE 106 White Plains, NY 10604 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-19 |
| Decision Date | 2010-07-27 |