FDA 510(k)

Mano and Mano Personal Lubricant

Номер K: K161585 · 2016-09-06

ЗаявительMano and Mano Proprietary Limited

Дата решения2016-09-06

Код продуктаNUC

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

Mano and Mano Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Mano and Mano Proprietary Limited. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161585. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Mano and Mano Personal Lubricant?

Mano and Mano Personal Lubricant is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Mano and Mano Proprietary Limited. The 510(k) number is K161585.

When did Mano and Mano Personal Lubricant receive FDA 510(k) clearance?

Mano and Mano Personal Lubricant received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161585.

Who is the listed applicant for Mano and Mano Personal Lubricant?

The FDA 510(k) record lists Mano and Mano Proprietary Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mano and Mano Personal Lubricant?

The FDA product code for Mano and Mano Personal Lubricant is NUC.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: NUC)

K260117EverslideSpecial Situations, LLC K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLC K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

Официальный источник

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