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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 K162207
FOIA Releasable 510(k) K162207
Device Name Restore Moisturizing Vaginal Lubricant
Good Clean Love
207 West 5th Avenue
Eugene,  OR  97401
Applicant Contact Wendy Strgar
S. Hesler Compliance Engineering
2602 5th Ave
West Linn,  OR  97068
Correspondent Contact Steve Hesler
Regulation Number884.5300
Classification Product Code
Date Received08/05/2016
Decision Date 05/04/2017
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