SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla— 510(k) K213547

Name: FDA 510(k) clearance K213547
Creator: U.S. Food and Drug Administration
Published: 2021-12-23

Substantially Equivalent

Ttk Healthcare Limited

FDA 510(k) clearance K213547 for SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla, Substantially Equivalent on 2021-12-23. Applicant: Ttk Healthcare Limited. Device class: 2.

Clearance details

Applicant: Ttk Healthcare Limited
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2021-11-08
Decision date: 2021-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Puducherry, IN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.