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FDA 510(k)

Water-soluble Personal Lubricant

K-Number: K212104 · 2021-11-18

ApplicantFoshan Pingchuang Medical Technology Co., Ltd.
Decision Date2021-11-18
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Water-soluble Personal Lubricant is a medical device manufactured by Foshan Pingchuang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under approval number K212104. 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 Water-soluble Personal Lubricant?

Water-soluble Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Foshan Pingchuang Medical Technology Co., Ltd.. The 510(k) number is K212104.

When was Water-soluble Personal Lubricant approved by the FDA?

Water-soluble Personal Lubricant received FDA 510(k) clearance on 2021-11-18, under approval number K212104.

What company makes Water-soluble Personal Lubricant?

Water-soluble Personal Lubricant is manufactured by Foshan Pingchuang Medical Technology Co., Ltd..

What is the FDA product code for Water-soluble Personal Lubricant?

The FDA product code for Water-soluble Personal Lubricant is NUC.

Other Devices by Foshan Pingchuang Medical Technology Co., Ltd.

K252935Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)

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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