FDA.report

510(k) K240379

Device
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
Applicant
Church & Dwight Co., Inc.
510(k) number
K240379
Product code
MOL
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-08
Date received
2024-02-07
Regulation
884.5300
Classification name
Condom, Synthetic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Lori Barr
Address
469 N. Harrison Streeet Princeton NJ US 08543 08543

FDA Registration Numbers

Source Documents

510(k) summary PDF

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