BabyDance Fertility Lubricant— 510(k) K162319

Name: FDA 510(k) clearance K162319
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Substantially Equivalent

Fairhaven Health, LLC

FDA 510(k) clearance K162319 for BabyDance Fertility Lubricant, Substantially Equivalent on 2017-04-28. Applicant: Fairhaven Health, LLC. Device class: 2.

Clearance details

Applicant: Fairhaven Health, LLC
Product code: Code PEB
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2016-08-19
Decision date: 2017-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellingham, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.