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510(k) K030177

ORLON NONABSORABLE SURGICAL SUTURE USP by Sri Orion Pharmaceuticals & Sutures — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2003
Date Received
January 17, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

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  • K192420 — Crownjun Nylon Suture (May 29, 2020)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
  • K152795 — RiverLon (Nylon) Suture (October 28, 2015)
  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)
  • K060471 — FSSB NYLON SURGICAL SUTURES (July 26, 2006)