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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Fairhaven Health, LLC. It received FDA 510(k) clearance on 2017-04-28 under 510(k) 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. The listed applicant is Fairhaven Health, LLC. The 510(k) number is K162319.

When did BabyDance Fertility Lubricant receive FDA 510(k) clearance?

BabyDance Fertility Lubricant received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162319.

Who is the listed applicant for BabyDance Fertility Lubricant?

The FDA 510(k) record lists Fairhaven Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BabyDance Fertility Lubricant?

The FDA product code for BabyDance Fertility Lubricant is PEB.

Other records listing Fairhaven Health, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190150Sage 2-in-1 Personal Lubricant and Moisturizer

Related Devices (Code: PEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212885Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLCK212705Actively Trying Personal Lubricant UnfragranceCC Wellness, LLCK193450Pre-Seed™ Fertility LubricantChurch & Dwight Co., Inc.K190872BioGenesis Fertility LubricantGood Clean Love, Inc.K182585JO Actively Trying Personal LubricantUnited Consortium

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.

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