SILICONE Personal Lubricant
K-Number: K191654 · 2020-04-14
Decision Date2020-04-14
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
SILICONE Personal Lubricant is a medical device manufactured by Bath Concept Cosmetics (Dongguan) Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under approval number K191654. 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 SILICONE Personal Lubricant?
SILICONE Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-04-14. It is manufactured by Bath Concept Cosmetics (Dongguan) Co., Ltd.. The 510(k) number is K191654.
When was SILICONE Personal Lubricant approved by the FDA?
SILICONE Personal Lubricant received FDA 510(k) clearance on 2020-04-14, under approval number K191654.
What company makes SILICONE Personal Lubricant?
SILICONE Personal Lubricant is manufactured by Bath Concept Cosmetics (Dongguan) Co., Ltd..
What is the FDA product code for SILICONE Personal Lubricant?
The FDA product code for SILICONE Personal Lubricant is 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.