510(k) K210208
K210208 is an FDA 510(k) premarket notification submitted by Titan Condoms, LLC for the device "Titan Condoms". The FDA issued a decision of Substantially Equivalent on February 17, 2022. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Titan Condoms, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2022
- Date Received
- January 26, 2021
- 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