LensGiene 灭菌生理盐水溶液
K号: K161622 · 2016-08-11
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决定日期2016-08-11
产品代码LPN
咨询委员会OP
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决定实质等同
器械摘要
LensGiene Sterile Saline Solution is the device name listed in this FDA 510(k) record. The listed applicant is Optics Laboratory, Inc.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K161622. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LensGiene Sterile Saline Solution?
LensGiene Sterile Saline Solution is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Optics Laboratory, Inc.. The 510(k) number is K161622.
When did LensGiene Sterile Saline Solution receive FDA 510(k) clearance?
LensGiene Sterile Saline Solution received FDA 510(k) clearance on 2016-08-11, under 510(k) number K161622.
Who is the listed applicant for LensGiene Sterile Saline Solution?
The FDA 510(k) record lists Optics Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LensGiene Sterile Saline Solution?
The FDA product code for LensGiene Sterile Saline Solution is LPN.
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相关器械（代码：LPN）
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。
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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