FDA 510(k)

SKORE Smooth 安全套 - SKORE 颜色与口味，SKORE Smooth 安全套 - SKORE 香草

K号: K213547 · 2021-12-23

决定日期2021-12-23

产品代码HIS

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决定实质等同

器械摘要

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla is the device name listed in this FDA 510(k) record. The listed applicant is Ttk Healthcare Limited. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K213547. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla?

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Ttk Healthcare Limited. The 510(k) number is K213547.

When did SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla receive FDA 510(k) clearance?

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla received FDA 510(k) clearance on 2021-12-23, under 510(k) number K213547.

Who is the listed applicant for SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla?

The FDA 510(k) record lists Ttk Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla?

The FDA product code for SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla is HIS.

列明Ttk Healthcare Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K230049SKORE Smooth，点状，超薄安全套 - SKORE 蓝色，SKORE 比利时巧克力，SKORE 点状，SKORE NOTHING 草莓，SKORE NOTHING 巧克力，SKORE SKIN THIN 超细；SKORE 膨胀安全套 - SKORE WARM，SKORE COOL；SKORE 苯佐卡因安全套 - SKORE NOTHING 高潮延迟，SKORE DUO MAX，SKORE NOT OUT K202403SKORE（颜色与口味），SKORE（颜色）

相关器械（代码：HIS）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262108FAMA男性乳胶避孕套 - 水性润滑剂（超薄型）；FAMA男性乳胶避孕套 - 水性润滑剂（普通型）；FAMA男性乳胶避孕套 - 水性润滑剂（肋纹型）；FAMA男性乳胶避孕套 - 水性润滑剂（点状型）；FAMA男性乳胶避孕套 - 水性润滑剂（非规则形状型）；MO男性乳胶避孕套 - 水性润滑剂（超薄型）；MO男性乳胶避孕套 - 水性润滑剂（普通型）；MO男性乳胶避孕套 - 水性润滑剂（肋纹型）；MO男性乳胶避孕套 - 水性润滑剂（点状型）；MOShanghai Personage Hygiene Products Co., Ltd.K252622男性乳胶避孕套HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel天然橡胶乳胶避孕套Suretex Limited K250034天然橡胶乳胶男用避孕套Shaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex 润滑天然乳胶安全套Lelo, Inc.K243640特洛伊™超细条纹Ecstasy乳胶避孕套（润滑型）（特洛伊™超细条纹Ecstasy）Church & Dwight Co., Inc.

官方来源

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