510(k) K180691
- Device
- TrueDorsal Devices
- Applicant
- True Function Laboratory, Inc.
- 510(k) number
- K180691
- Product code
- LRK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-11
- Date received
- 2018-03-16
- Regulation
- 872.5570
- Classification name
- Device, Anti-snoring
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Frank Madrigal
- Address
- 7851 University Ave., #102 La Mesa CA US 91942 91942
FDA Registration Numbers#
- 3005598536
- 3011649314
- 3015169722
- 3006038700
- 3008102163
- 3023272766
- 3012359952
- 3021282544
- 3000126629
- 3003283852
- 1316408
- 1825660
- 3015674959
- 3015128224
- 2518422
- 3005730680
- 3008583502
- 3009132214
- 3005726841
- 3007616887
- 3030562551
- 3017520337
- 3004964738
- 3006794225
- 3010324114
- 3002916277
- 3008797926
- 3004748290
- 2031093
- 3006650414
- 3031282374
- 3010852338
- 3025124
- 9614473
- 3031978086
- 1420088
- 1045254
- 3009495876
- 3013116677
- 3002911411
- 3017092365
- 3013950969
- 3010767848
- 3027346720
- 3010022489
- 3016674860
- 3007108578
- 3009549313
- 3002706372
- 3027579589
- 3003928050
- 3008313791
- 9615291
- 3006098230
- 3013445151
- 3039643908
- 3028271666
- 3021841051
- 3002912391
- 3014680794
- 3012539501
- 3012716038
- 3039443708
- 3003460151
- 3018094310
- 3017567754
- 3038209294
- 3013548547
- 3043364471
- 3012728846
- 3010347083
- 1000118628
- 3009779268
- 3013156109
- 3007233968
- 3009440973
- 3004038575
- 3010358861
- 1937100
- 3008808087
Source Documents#
510(k) summary PDF not indicated by FDA
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