The following data is part of a premarket notification filed by Prestige Brands, Inc. with the FDA for The Doctor's Nightguard Advanced Comfort.
| Device ID | K073220 |
| 510k Number | K073220 |
| Device Name: | THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT |
| Classification | Mouthguard, Over-the-counter |
| Applicant | PRESTIGE BRANDS, INC. 90 N BROADWAY Irvington, NY 10533 |
| Contact | Karen A Costa-strachan |
| Correspondent | Karen A Costa-strachan PRESTIGE BRANDS, INC. 90 N BROADWAY Irvington, NY 10533 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-15 |
| Decision Date | 2007-12-19 |
| Summary: | summary |