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510(k) K080216

SUPRAMESH EXTRA by S. Jackson, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2008
Date Received
January 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by S. Jackson, Inc.

  • K973379 — STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS (September 25, 1997)
  • K931612 — NYLAMID SUTURE (December 17, 1993)
  • K931614 — MOPYLEN SUTURE (December 17, 1993)
  • K931613 — SUPRAMID SUTURE (December 17, 1993)
  • K922630 — MOPYLEN (October 20, 1992)
  • K912429 — N80-838 SUPRAMID EXTRA SUTURE (October 2, 1991)
  • 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)
  • K831724 — CHIN (MENTOPLASTY) IMPLANTS (August 12, 1983)

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