BabyDance Fertility Lubricant
K-Number: K162319 · 2017-04-28
ApplicantFairhaven Health, LLC
Decision Date2017-04-28
Product CodePEB
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
BabyDance Fertility Lubricant is a medical device manufactured by Fairhaven Health, LLC. It received FDA 510(k) clearance on 2017-04-28 under approval number K162319. The device is classified under product code PEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BabyDance Fertility Lubricant?
BabyDance Fertility Lubricant is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Fairhaven Health, LLC. The 510(k) number is K162319.
When was BabyDance Fertility Lubricant approved by the FDA?
BabyDance Fertility Lubricant received FDA 510(k) clearance on 2017-04-28, under approval number K162319.
What company makes BabyDance Fertility Lubricant?
BabyDance Fertility Lubricant is manufactured by Fairhaven Health, LLC.
What is the FDA product code for BabyDance Fertility Lubricant?
The FDA product code for BabyDance Fertility Lubricant is PEB.
Other Devices by Fairhaven Health, LLC
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.