510(k) K034017

Device
JEJE TEETHER
Applicant
VIBE 2000
510(k) number
K034017
Product code
MEF  
Decision
Substantially Equivalent (SESE)
Decision date
2004-10-18
Date received
2003-12-24
Regulation
872.5550
Classification name
Ring, Teething, Non-fluid Filled
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAROL PATTERSON
Address
21911 Erie Ln. Lake Forest CA US 93030 93030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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