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510(k) K913794

SIMPEX INC. SURGICAL DRESSING by Simpex, Inc. — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1991
Date Received
August 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

Other clearances by Simpex, Inc.

  • K920174 — EASY TOUCH LATEX EAM GLOVES (April 22, 1992)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)
  • K911505 — FIXATION WIRE (April 12, 1991)
  • K911452 — FIXATION PIN (April 12, 1991)

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  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (February 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953057 — CYLINDRICAL SPONGE (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)