510(k) K230049 ยท HIS Condom
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
| Applicant | Ttk Healthcare Limited, Puducherry, IN |
| Decision | Substantially Equivalent, Sep 7, 2023 |
| Received | Jan 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230049
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.