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510(k) K912429

N80-838 SUPRAMID EXTRA SUTURE by S. Jackson, Inc. — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1991
Date Received
May 31, 1991
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)
  • K904052 — SUPRAMID EXTRA SUTURES (October 25, 1990)
  • 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)

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  • 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)