FDA 510(k)

Rondek PGA Suture (Beige or Violet)

Número K: K180625 · 2018-05-10

Data da decisão2018-05-10

Código do produtoGAM

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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