The following data is part of a premarket notification filed by True Function Laboratory, Inc. with the FDA for True Function Adjustable Herbst Appliances.
| Device ID | K170578 |
| 510k Number | K170578 |
| Device Name: | True Function Adjustable Herbst Appliances |
| 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 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-27 |
| Decision Date | 2017-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001703009 | K170578 | 000 |