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510(k) K180764

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) by Church & Dwight Co., Inc. — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2018
Date Received
March 23, 2018
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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