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#
- 3006707038
- 3004957421
- 2032476
- 3004529379
- 3010822231
- 3005031124
- 3008138005
- 3010595767
- 3005980667
- 3013927145
- 3007838093
- 3010626066
- 3008191511
- 3009926836
- 3043648115
- 3033435481
- 3008687634
- 3016195105
- 1217805
- 3015485146
- 8043323
- 3027986540
- 3009171220
- 2183416
- 3006542501
- 3014538098
- 3025358043
- 3012134276
- 3026986849
- 3011182134
- 3006852457
- 3031903546
- 3002857192
- 3017979984
- 3025421697
- 3006610790
- 3008478778
- 3000182940
- 3016245319
- 3010408556
- 3017896176
- 3007113231
- 3003270419
- 3007154355
- 3008711096
- 3012428275
- 3021340005
- 3009881291
- 3022575228
- 3013549008
- 3005505603
- 2110540
- 3029906449
- 3009109684
- 3007608864
- 3007748805
- 3008395516
- 2381321
- 3011530693
- 3014085509
- 3038195017
- 3011322033
- 3020317922
- 3008381928
- 3010163706
- 3014367318
- 3011584003
- 3014921777
- 3008729914
- 3042256682
- 3006891667
- 3009124884
- 3012684779
- 3010332886
- 3008650974
- 3015168527
- 3012416077
- 3027320022
- 3010337881
Source Documents#
Legacy Summary#
summary
FDA Review#
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