Kerecis 口腔
K号: K213904 · 2022-09-30
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申请人Kerecis
决定日期2022-09-30
产品代码NPL
咨询委员会DE
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决定实质等同
器械摘要
Kerecis Oral is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K213904. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Kerecis Oral?
Kerecis Oral is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Kerecis. The 510(k) number is K213904.
When did Kerecis Oral receive FDA 510(k) clearance?
Kerecis Oral received FDA 510(k) clearance on 2022-09-30, under 510(k) number K213904.
Who is the listed applicant for Kerecis Oral?
The FDA 510(k) record lists Kerecis as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kerecis Oral?
The FDA product code for Kerecis Oral is NPL.
相关临床试验
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相关器械（代码：NPL）
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
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