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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 K250629
Device Name Sutil Rich Personal Lubricant
Applicant
Hathor Professional Skincare , Ltd.
2618 Roseberry Ave.
Victoria,  CA V8R 3T7
Applicant Contact Carolyn (Mellta) Swift
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Rob Packard
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/03/2025
Decision Date 05/02/2025
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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