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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K261905
Device Name BUM Oil
Applicant
Bumlicious, LLC (DBA “Bumlicious”)
515 E. Las Olas Blvd.
Suite 1301-K25
Fort Lauderdale,  FL  33301
Applicant Contact Louie Goryoka
Correspondent
Bumlicious, LLC (DBA “Bumlicious”)
515 E. Las Olas Blvd.
Suite 1301-K25
Fort Lauderdale,  FL  33301
Correspondent Contact Louie Goryoka
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/08/2026
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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