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510(k) K242645

INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant by Project Chemistry, Inc. — Product Code NUC

K242645 is an FDA 510(k) premarket notification submitted by Project Chemistry, Inc. for the device "INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant". The FDA issued a decision of Substantially Equivalent on Dec 6, 2024. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 6, 2024
Date Received
Sep 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

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FDA data resources