KeraStat(R) 凝胶
K号: K162759 · 2017-06-02
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器械摘要
KeraStat(R) Gel is the device name listed in this FDA 510(k) record. The listed applicant is Keranetics, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K162759. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.
常见问题
What is the KeraStat(R) Gel?
KeraStat(R) Gel is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Keranetics, LLC. The 510(k) number is K162759.
When did KeraStat(R) Gel receive FDA 510(k) clearance?
KeraStat(R) Gel received FDA 510(k) clearance on 2017-06-02, under 510(k) number K162759.
Who is the listed applicant for KeraStat(R) Gel?
The FDA 510(k) record lists Keranetics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KeraStat(R) Gel?
The FDA product code for KeraStat(R) Gel is KGN.
相关临床试验
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相关器械（代码：KGN）
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。
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官方来源
在 FDA 数据库中查看 →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。
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