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510(k) K973379

STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS by S. Jackson, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1997
Date Received
September 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by S. Jackson, Inc.

  • K080216 — SUPRAMESH EXTRA (September 15, 2008)
  • 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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