The following data is part of a premarket notification filed by Mckeon Products with the FDA for Lunaguard Nighttime Dental Protector.
| Device ID | K191033 |
| 510k Number | K191033 |
| Device Name: | LunaGuard Nighttime Dental Protector |
| Classification | Mouthguard, Over-the-counter |
| Applicant | McKeon Products 25460 Guenther Warren, MI 48091 |
| Contact | Devin Benner |
| Correspondent | Elizabeth Fitzgerald Right Submission LLC 59 High Street Newton, MA 02464 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-18 |
| Decision Date | 2019-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00033732010306 | K191033 | 000 |