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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 K242645
Device Name INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
Applicant
Project Chemistry, Inc.
18241 Gothard St.
Huntington Beach,  CA  92648
Applicant Contact Jessica Graham
Correspondent
Med-Device Consulting, Inc.
5804 Rainbow Hill Rd.
Agoura Hills,  CA  91301
Correspondent Contact Louie Goryoka
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/03/2024
Decision Date 12/06/2024
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
Predetermined Change
Control Plan Authorized		 No
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