The following data is part of a premarket notification filed by Evenflo Company, Inc. with the FDA for Berry Fruity Teether.
| Device ID | K053493 |
| 510k Number | K053493 |
| Device Name: | BERRY FRUITY TEETHER |
| Classification | Ring, Teething, Fluid-filled |
| Applicant | EVENFLO COMPANY, INC. 707 CROSSROADS COURT Vandalia, OH 45377 |
| Contact | Ruben D Colmenares |
| Correspondent | Ruben D Colmenares EVENFLO COMPANY, INC. 707 CROSSROADS COURT Vandalia, OH 45377 |
| Product Code | KKO |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-15 |
| Decision Date | 2006-02-22 |