Rondek PGA Suture (Beige or Violet)
K-Number: K180625 · 2018-05-10
ApplicantRk Manufacturing Corporation
Decision Date2018-05-10
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Rondek PGA Suture (Beige or Violet) is a medical device manufactured by Rk Manufacturing Corporation. It received FDA 510(k) clearance on 2018-05-10 under approval number K180625. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Rk Manufacturing Corporation. The 510(k) number is K180625.
When was Rondek PGA Suture (Beige or Violet) approved by the FDA?
Rondek PGA Suture (Beige or Violet) received FDA 510(k) clearance on 2018-05-10, under approval number K180625.
What company makes Rondek PGA Suture (Beige or Violet)?
Rondek PGA Suture (Beige or Violet) is manufactured by Rk Manufacturing Corporation.
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.