FDA 510(k)

SUNTOUCH 牙科敷料

K号: K173196 · 2018-01-24

申请人Huizhou Foryou Medical Devices Co., Ltd.

决定日期2018-01-24

产品代码OLR

决定实质等同

器械摘要

SUNTOUCH Dental Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-01-24 under 510(k) number K173196. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

常见问题

What is the SUNTOUCH Dental Dressing?

SUNTOUCH Dental Dressing is a medical device that received FDA 510(k) clearance on 2018-01-24. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K173196.

When did SUNTOUCH Dental Dressing receive FDA 510(k) clearance?

SUNTOUCH Dental Dressing received FDA 510(k) clearance on 2018-01-24, under 510(k) number K173196.

Who is the listed applicant for SUNTOUCH Dental Dressing?

FDA 510(k)记录将惠州友康医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for SUNTOUCH Dental Dressing?

The FDA product code for SUNTOUCH Dental Dressing is OLR.

列明Huizhou Foryou Medical Devices Co., Ltd.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。

K254256LUOFUCON® 创面基质 K250642LUOFUCON® 皮肤和伤口清洁剂（喷雾、雾状、挤压、瓶装）K240809LUOFUCON® 银胶原敷料 K242856LUOFUCON® 硅胶银离子泡沫敷料（处方用药）/ LUOFUCON® 硅胶银离子抗菌泡沫敷料（非处方用药）(边缘型、边缘型轻便、无边缘型和转移型)K240485LUOFUCON® 额外银凝胶纤维敷料 Plus（处方用药），LUOFUCON® 银抗菌凝胶纤维敷料 Plus（非处方用药）K232796LUOFUCON® 胶原颗粒（胶原蛋白伤口敷料）

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。