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510(k) Data Aggregation
K Number
K180625Device Name
Rondek PGA Suture (Beige or Violet)
Manufacturer
Date Cleared
2018-05-10
(62 days)
Product Code
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
RK Manufacturing Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Rondek PGA suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Device Description
RK's Rondek PGA suture is a sterile, absorbable, braided suture composed of a homopolymer of glycolic acid and coated with a copolymer of Polycaprolactone and Polyglycolic acid.
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