The following data is part of a premarket notification filed by Respire Medical Holding with the FDA for Respire Pink Series With Dentitrac.
| Device ID | K170692 |
| 510k Number | K170692 |
| Device Name: | Respire Pink Series With DentiTrac |
| Classification | Device, Anti-snoring |
| Applicant | Respire Medical Holding 18 Bridge Street, Suite 4J Brooklyn, NY 11201 |
| Contact | Jonathan Sandler |
| Correspondent | Jonathan Sandler Respire Medical Holding 18 Bridge Street, Suite 4J Brooklyn, NY 11201 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2017-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851861007246 | K170692 | 000 |
| 00851861007239 | K170692 | 000 |
| 00851861007222 | K170692 | 000 |
| 00851861007215 | K170692 | 000 |
| 00851861007208 | K170692 | 000 |
| 00851861007192 | K170692 | 000 |
| 00851861007185 | K170692 | 000 |
| 00851861007178 | K170692 | 000 |
| 00851861007161 | K170692 | 000 |