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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, gamete, fertilization, and embryo compatible
510(k) Number K162319
Device Name BabyDance Fertility Lubricant
Applicant
Fairhaven Health, LLC
1410 11th St
Bellingham,  WA  98225
Applicant Contact Suzanne Munson
Correspondent
Fairhaven Health, LLC
1410 11th St
Bellingham,  WA  98225
Correspondent Contact Suzanne Munson
Regulation Number884.5300
Classification Product Code
PEB  
Date Received08/19/2016
Decision Date 04/28/2017
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
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