FDA 510(k)

Gebauer的疼痛缓解局部麻醉剂皮肤冷却剂（雾喷和中等喷雾）

K号: K172028 · 2017-10-27

决定日期2017-10-27

产品代码MLY

决定实质等同

器械摘要

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is the device name listed in this FDA 510(k) record. The listed applicant is Gebauer Company. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K172028. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常见问题

What is the Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Gebauer Company. The 510(k) number is K172028.

When did Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) receive FDA 510(k) clearance?

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) received FDA 510(k) clearance on 2017-10-27, under 510(k) number K172028.

Who is the listed applicant for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

FDA 510(k)记录显示Gebauer公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

The FDA product code for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is MLY.

列明Gebauer Company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。

K260870Gebauer的疼痛缓解局部麻醉皮肤制冷剂（雾状喷剂和中号喷剂）K190161乙醚氯气中射流，乙醚氯气细点喷，乙醚氯气雾，乙醚氯气Accustream 360*中喷，乙醚氯气Accustream 360*细喷

官方来源

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