The following data is part of a premarket notification filed by Crane Dental Laboratory, Inc with the FDA for Sapphire Dorsal Comfort Fit.
| Device ID | K181416 |
| 510k Number | K181416 |
| Device Name: | Sapphire Dorsal Comfort Fit |
| Classification | Device, Anti-snoring |
| Applicant | Crane Dental Laboratory, Inc 3515 Buffalo Road Suite 30 Rochester, NY 14624 |
| Contact | Sharlene Schultz |
| Correspondent | Sharlene Schultz Crane Dental Laboratory, Inc 3515 Buffalo Road Suite 30 Rochester, NY 14624 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-31 |
| Decision Date | 2019-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009255609 | K181416 | 000 |