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510(k) K193444

Vagisan MoistCream Cremolum by Dr. August Wolff GmbH & Co. KG Arzneimittel — Product Code NUC

K193444 is an FDA 510(k) premarket notification submitted by Dr. August Wolff GmbH & Co. KG Arzneimittel for the device "Vagisan MoistCream Cremolum". The FDA issued a decision of Substantially Equivalent on Dec 4, 2020. 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 4, 2020
Date Received
Dec 12, 2019
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
510(k)

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