510(k) K034017
K034017 is an FDA 510(k) premarket notification submitted by Vibe 2000 for the device "JEJE TEETHER". The FDA issued a decision of Substantially Equivalent on October 18, 2004. The device falls under product code MEF (Ring, Teething, Non-Fluid Filled), a Class I device regulated under 21 CFR 872.5550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2004
- Date Received
- December 24, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring, Teething, Non-Fluid Filled
- Device Class
- Class I
- Regulation Number
- 872.5550
- Review Panel
- DE
- Submission Type