510(k) K213547

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla by Ttk Healthcare Limited — Product Code HIS

K213547 is an FDA 510(k) premarket notification submitted by Ttk Healthcare Limited for the device "SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla". The FDA issued a decision of Substantially Equivalent on December 23, 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.