FDA 510(k)

SB 软帽 - 直型，SB 软帽 - 下切型

K号: K173004 · 2018-05-08

决定日期2018-05-08

产品代码FDS

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决定实质等同

器械摘要

SB Soft Hood - Straight type, SB Soft Hood - Undercut type is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K173004. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Sumitomo Bakelite Co., Ltd.. The 510(k) number is K173004.

When did SB Soft Hood - Straight type, SB Soft Hood - Undercut type receive FDA 510(k) clearance?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type received FDA 510(k) clearance on 2018-05-08, under 510(k) number K173004.

Who is the listed applicant for SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

The FDA 510(k) record lists Sumitomo Bakelite Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

The FDA product code for SB Soft Hood - Straight type, SB Soft Hood - Undercut type is FDS.

列明Sumitomo Bakelite Co., Ltd.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。

K182520柔性外套管 K190621SB 刀/短型，SB 刀/标准型，SB 刀/Jr 型，SB 刀/Jr 型 - 长 K152771SB 刀 Jr 型，SB 刀短型，SB 刀标准型，SB 刀 Jr 型 - 长

官方来源

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