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FDA 510(k)

Astroglide O Oil Personal Lubricant & Massage Oil

K-Number: K171985 · 2017-08-30

ApplicantBiofilm, Inc.
Decision Date2017-08-30
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Astroglide O Oil Personal Lubricant & Massage Oil is a medical device manufactured by Biofilm, Inc.. It received FDA 510(k) clearance on 2017-08-30 under approval number K171985. 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 Astroglide O Oil Personal Lubricant & Massage Oil?

Astroglide O Oil Personal Lubricant & Massage Oil is a medical device that received FDA 510(k) clearance on 2017-08-30. It is manufactured by Biofilm, Inc.. The 510(k) number is K171985.

When was Astroglide O Oil Personal Lubricant & Massage Oil approved by the FDA?

Astroglide O Oil Personal Lubricant & Massage Oil received FDA 510(k) clearance on 2017-08-30, under approval number K171985.

What company makes Astroglide O Oil Personal Lubricant & Massage Oil?

Astroglide O Oil Personal Lubricant & Massage Oil is manufactured by Biofilm, Inc..

What is the FDA product code for Astroglide O Oil Personal Lubricant & Massage Oil?

The FDA product code for Astroglide O Oil Personal Lubricant & Massage Oil is NUC.

Other Devices by Biofilm, Inc.

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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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