FDA 510(k)

Embozene Color-Advanced Microspheres

K号: K180102 · 2018-04-19

决定日期2018-04-19

产品代码NOY

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决定实质等同

器械摘要

Embozene Color-Advanced Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K180102. The device is classified under product code NOY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Embozene Color-Advanced Microspheres?

Embozene Color-Advanced Microspheres is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Boston Scientific. The 510(k) number is K180102.

When did Embozene Color-Advanced Microspheres receive FDA 510(k) clearance?

Embozene Color-Advanced Microspheres received FDA 510(k) clearance on 2018-04-19, under 510(k) number K180102.

Who is the listed applicant for Embozene Color-Advanced Microspheres?

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Embozene Color-Advanced Microspheres?

The FDA product code for Embozene Color-Advanced Microspheres is NOY.

列明Boston Scientific为申报人的其他记录

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