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510(k) K904052

SUPRAMID EXTRA SUTURES by S. Jackson, Inc. — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1990
Date Received
August 29, 1990
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 S. Jackson, Inc.

  • K080216 — SUPRAMESH EXTRA (September 15, 2008)
  • K973379 — STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS (September 25, 1997)
  • K931612 — NYLAMID SUTURE (December 17, 1993)
  • K931613 — SUPRAMID SUTURE (December 17, 1993)
  • K931614 — MOPYLEN SUTURE (December 17, 1993)
  • K922630 — MOPYLEN (October 20, 1992)
  • K912429 — N80-838 SUPRAMID EXTRA SUTURE (October 2, 1991)
  • K852011 — NYLAMID MESH PAD FULL & HALF (June 11, 1985)
  • K831725 — FOIL IN 3 FORMS-NON-STERILE SHEETS (August 16, 1983)
  • K831727 — QUARTER GLOBE CAPS (August 12, 1983)

Other clearances for product code GAR

  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • K212888 — Golnit Nylon Monofilament Suture (March 31, 2022)
  • K212603 — Non Absorbable Surgical Nylon Suture (December 22, 2021)
  • 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)