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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 K150094
Device Name Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
Good Clean Love, Inc.
207 West 5th Avenue
Eugene,  OR  97401
Applicant Contact Wendy Strgar
Drug & Device Development Co., Inc.
P.O. Box 3515
Redmont,  WA  98073
Correspondent Contact Steven Chernoff
Regulation Number884.5300
Classification Product Code
Date Received01/16/2015
Decision Date 11/19/2015
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