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— 510(k) K230049
Substantially EquivalentTtk Healthcare Limited
FDA 510(k) clearance K230049 for 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, Substantially Equivalent on 2023-09-07. Applicant: Ttk Healthcare Limited.
Clearance details
- Applicant
- Ttk Healthcare Limited
- Product code
- Code HIS
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Puducherry, IN
Data sourced from openFDA. This site is unofficial and independent of the FDA.