The following data is part of a premarket notification filed by Dreamgard, Inc. with the FDA for Dreamgard Rem-soft, Dreamgard Rem-lite, Dreamgard Rem-ultra, Dreamgard Rem-max.
| Device ID | K112868 |
| 510k Number | K112868 |
| Device Name: | DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX |
| Classification | Mouthguard, Prescription |
| Applicant | DREAMGARD, INC. 1601 K STREET, NW Washington, DC 20006 |
| Contact | Suzan Onel |
| Correspondent | Suzan Onel DREAMGARD, INC. 1601 K STREET, NW Washington, DC 20006 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-01-19 |
| Summary: | summary |