510(k) K202403
K202403 is an FDA 510(k) premarket notification submitted by Ttk Healthcare Limited for the device "SKORE (Colors & Flavors), SKORE (Colors)". The FDA issued a decision of Substantially Equivalent on April 15, 2021. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ttk Healthcare Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2021
- Date Received
- August 21, 2020
- 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