FDA 510(k)

Rondek PGA 缝线（米色或紫色）

K号: K180625 · 2018-05-10

决定日期2018-05-10

产品代码GAM

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决定实质等同

器械摘要

Rondek PGA Suture (Beige or Violet) is the device name listed in this FDA 510(k) record. The listed applicant is Rk Manufacturing Corporation. It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K180625. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rondek PGA Suture (Beige or Violet)?

Rondek PGA Suture (Beige or Violet) is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Rk Manufacturing Corporation. The 510(k) number is K180625.

When did Rondek PGA Suture (Beige or Violet) receive FDA 510(k) clearance?

Rondek PGA Suture (Beige or Violet) received FDA 510(k) clearance on 2018-05-10, under 510(k) number K180625.

Who is the listed applicant for Rondek PGA Suture (Beige or Violet)?

The FDA 510(k) record lists Rk Manufacturing Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rondek PGA Suture (Beige or Violet)?

The FDA product code for Rondek PGA Suture (Beige or Violet) is GAM.

相关器械（代码：GAM）

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。

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官方来源

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器械摘要

常见问题

相关临床试验

相关器械（代码：GAM）

官方来源