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510(k) K932846

TENCEL X-RAY DETECTABLE SPONGES/LAP PADS by Courtaulds Fibers, Inc. — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1993
Date Received
June 10, 1993
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 Courtaulds Fibers, Inc.

  • K972458 — LYOCELL WOUND DRESSING/SURGICAL SPONGE (September 19, 1997)
  • K921227 — TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE (May 29, 1992)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K960236 — CPR LAP SPONGES (March 28, 1996)
  • 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)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953057 — CYLINDRICAL SPONGE (September 14, 1995)