Exofin 高粘度组织粘合剂
K号: K152476 · 2016-02-09
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决定日期2016-02-09
产品代码MPN
咨询委员会SU
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决定实质等同
器械摘要
Exofin High Viscosity Tissue Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical Products, Inc.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K152476. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Exofin High Viscosity Tissue Adhesive?
Exofin High Viscosity Tissue Adhesive is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Chemence Medical Products, Inc.. The 510(k) number is K152476.
When did Exofin High Viscosity Tissue Adhesive receive FDA 510(k) clearance?
Exofin High Viscosity Tissue Adhesive received FDA 510(k) clearance on 2016-02-09, under 510(k) number K152476.
Who is the listed applicant for Exofin High Viscosity Tissue Adhesive?
The FDA 510(k) record lists Chemence Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Exofin High Viscosity Tissue Adhesive?
The FDA product code for Exofin High Viscosity Tissue Adhesive is MPN.
相关临床试验
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。
相关器械（代码：MPN）
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。
K243990BondEase 2 表面皮肤粘合剂Optmed, Inc.K250950CUTIVA™局部皮肤粘合剂（RM1700）；CUTIVA™ PLUS皮肤闭合系统（RM1739）Okapi Medical, LLC Dba Resivant MedicalK234114CUTIVA™局部皮肤粘合剂（RM-1700）；CUTIVA™ PLUS皮肤闭合系统（RM-1739）Okapi Medical, LLC Dba Resivant MedicalK233458CM005 标准 (CM005)；CM004 迷你 (CM004)Connexicon Medical , Ltd.K230981Meriglu局部皮肤粘合剂M/s. Meril Endo Surgery Private Limited.K212246Exofin 精密笔Chemence Medical, Inc.
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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