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510(k) K041510

TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE by Sutures India Private Limited — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2005
Date Received
June 7, 2004
Clearance Type
Traditional
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

Other clearances by Sutures India Private Limited

  • K041514 — TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE (June 3, 2005)
  • K041511 — TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE (June 3, 2005)
  • K041512 — NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE (June 2, 2005)
  • K041515 — TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE (April 8, 2005)

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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)