The following data is part of a premarket notification filed by True Function Laboratory, Inc. with the FDA for Truedorsal Devices.
Device ID | K180691 |
510k Number | K180691 |
Device Name: | TrueDorsal Devices |
Classification | Device, Anti-snoring |
Applicant | True Function Laboratory, Inc. 7851 University Ave., #102 La Mesa, CA 91942 |
Contact | Frank Madrigal |
Correspondent | Nicolas Azar Azar & Associates PO Box 800914 Santa Clarita, CA 91380 -0914 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-16 |
Decision Date | 2019-02-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860001703016 | K180691 | 000 |