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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 K190150
Device Name Sage 2-in-1 Personal Lubricant and Moisturizer
Fairhaven Health, LLC
1410 11th St
Bellingham,  WA  98225
Applicant Contact Suzanne Munson
Fairhaven Health, LLC
1410 11th St
Bellingham,  WA  98225
Correspondent Contact Suzanne Munson
Regulation Number884.5300
Classification Product Code
Date Received01/30/2019
Decision Date 07/16/2019
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