The following data is part of a premarket notification filed by Vibe 2000 with the FDA for Jeje Teether.
| Device ID | K034017 |
| 510k Number | K034017 |
| Device Name: | JEJE TEETHER |
| Classification | Ring, Teething, Non-fluid Filled |
| Applicant | VIBE 2000 21911 ERIE LANE Lake Forest, CA 93030 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson VIBE 2000 21911 ERIE LANE Lake Forest, CA 93030 |
| Product Code | MEF |
| CFR Regulation Number | 872.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-10-18 |
| Summary: | summary |