JEJE TEETHER
FDA 510(k) clearance K034017 · decided 2004-10-18
Clearance details
- K-number
- K034017
- Device name
- JEJE TEETHER
- Applicant
- Vibe 2000
- Decision
- Substantially Equivalent
- Date received
- 2003-12-24
- Decision date
- 2004-10-18
- Days to decision
- 299 days
- Clearance type
- Traditional
- Product code
- MEF
- Device class
- 1
- Regulation number
- 872.5550
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.