The following data is part of a premarket notification filed by Brazen Goods Inc. Dba Lorals with the FDA for Lorals.
| Device ID | K212928 |
| 510k Number | K212928 |
| Device Name: | Lorals |
| Classification | Barrier, Std, Oral Sex |
| Applicant | Brazen Goods Inc. Dba Lorals 106 1/2 Judge John Aiso St. #305 Los Angeles, CA 90012 |
| Contact | Melanie Cristol |
| Correspondent | Erin Gontang AcKnowledge Regulatory Strategies LLC 2251 San Diego Ave, B-257 San Diego, CA 92110 |
| Product Code | MSC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-14 |
| Decision Date | 2022-04-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LORALS 87202579 not registered Live/Pending |
BRAZEN GOODS INC. 2016-10-13 |
![]() LORALS 87202513 not registered Live/Pending |
BRAZEN GOODS INC. 2016-10-13 |
![]() LORALS 72129184 0734654 Dead/Expired |
AMERICAN CHICLE COMPANY 1961-10-04 |