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FDA 510(k)

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer

K-Number: K162569 · 2017-06-09

ApplicantBiotech Lubricants, Ltd.
Decision Date2017-06-09
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer is a medical device manufactured by Biotech Lubricants, Ltd.. It received FDA 510(k) clearance on 2017-06-09 under approval number K162569. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer?

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer is a medical device that received FDA 510(k) clearance on 2017-06-09. It is manufactured by Biotech Lubricants, Ltd.. The 510(k) number is K162569.

When was YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer approved by the FDA?

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer received FDA 510(k) clearance on 2017-06-09, under approval number K162569.

What company makes YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer?

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer is manufactured by Biotech Lubricants, Ltd..

What is the FDA product code for YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer?

The FDA product code for YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer is NUC.

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Related PubMed Literature

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Related Devices (Code: NUC)

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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.

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