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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name barrier, std, oral sex
510(k) Number K212928
Device Name Lorals
Brazen Goods Inc. dba Lorals
106 1/2 Judge John Aiso St. #305
Los Angeles,  CA  90012
Applicant Contact Melanie Cristol
AcKnowledge Regulatory Strategies LLC
2251 San Diego Ave, B-257
San Diego,  CA  92110
Correspondent Contact Erin Gontang
Regulation Number884.5300
Classification Product Code
Date Received09/14/2021
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