FDA 510(k)

Water Solubility Human Body Lubricant

Número K: K243107 · 2025-05-09

RequerenteDongguan Yanxuan Biotechnology Co., Ltd.

Data da decisão2025-05-09

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Water Solubility Human Body Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Yanxuan Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K243107. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Water Solubility Human Body Lubricant?

Water Solubility Human Body Lubricant is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Dongguan Yanxuan Biotechnology Co., Ltd.. The 510(k) number is K243107.

When did Water Solubility Human Body Lubricant receive FDA 510(k) clearance?

Water Solubility Human Body Lubricant received FDA 510(k) clearance on 2025-05-09, under 510(k) number K243107.

Who is the listed applicant for Water Solubility Human Body Lubricant?

The FDA 510(k) record lists Dongguan Yanxuan Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Water Solubility Human Body Lubricant?

The FDA product code for Water Solubility Human Body Lubricant is NUC.

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