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510(k) K193450

Pre-Seed™ Fertility Lubricant by Church & Dwight Co., Inc. — Product Code PEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2020
Date Received
December 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.

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