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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 K252914
Device Name Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
Applicant
Hathor Professional Skincare , Ltd.
P.O. Box 23027
Cook St. R.P.O
Victoria,  CA V8T 3S6
Applicant Contact Carolyn (Mellta) Swift
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Gregory Chrysler
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/12/2025
Decision Date 06/09/2026
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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