510(k) K243640
K243640 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)". The FDA issued a decision of Substantially Equivalent on February 21, 2025. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2025
- Date Received
- November 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type