Device Classification Name |
barrier, std, oral sex
|
510(k) Number |
K212928 |
Device Name |
Lorals |
Applicant |
Brazen Goods Inc. dba Lorals |
106 1/2 Judge John Aiso St. #305 |
Los Angeles,
CA
90012
|
|
Applicant Contact |
Melanie Cristol |
Correspondent |
AcKnowledge Regulatory Strategies LLC |
2251 San Diego Ave, B-257 |
San Diego,
CA
92110
|
|
Correspondent Contact |
Erin Gontang |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 09/14/2021 |
Decision Date | 04/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|