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 |