FDA 510(k)

DSM Biomedical 牙科骨移植

K号: K170245 · 2017-05-16

申请人Kensey Nash Corporation Dba Dsm Biomedical

决定日期2017-05-16

产品代码NPM

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决定实质等同

器械摘要

DSM Biomedical Dental Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K170245. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DSM Biomedical Dental Bone Graft?

DSM Biomedical Dental Bone Graft is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. The 510(k) number is K170245.

When did DSM Biomedical Dental Bone Graft receive FDA 510(k) clearance?

DSM Biomedical Dental Bone Graft received FDA 510(k) clearance on 2017-05-16, under 510(k) number K170245.

Who is the listed applicant for DSM Biomedical Dental Bone Graft?

The FDA 510(k) record lists Kensey Nash Corporation Dba Dsm Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSM Biomedical Dental Bone Graft?

The FDA product code for DSM Biomedical Dental Bone Graft is NPM.

列明Kensey Nash Corporation Dba Dsm Biomedical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。

K173572DSM Biomedical 磷酸钙水泥微球 K173362DSM 生物医学磷酸钙水泥 K160474DSM Biomedical 猪心包牙膜

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