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510(k) K882708

GAUZE SPONGE, X-RAY DETECTABLE by Bioseal — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1988
Date Received
June 27, 1988
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 Bioseal

  • K893814 — SURGICAL INSTRUMENT KIT, DISPOSABLE (August 10, 1989)
  • K882695 — RUBBER BAND, STERILE (October 13, 1988)
  • K882696 — DERMICEL, MONTGOMERY STRAP (August 26, 1988)
  • K882694 — FIXATION DEVICE, TRACH TUBE (August 15, 1988)
  • K882707 — GAUZE PACKING, X-RAY DETECTABLE (August 3, 1988)
  • K882711 — GAUZE SPONGE 12PLY (August 3, 1988)
  • K882712 — STICK SPONGE (August 3, 1988)
  • K882709 — TONSIL SPONGE, X-RAY DETECTABLE, W/STRING (August 3, 1988)
  • K882710 — INTESTINAL SPONGES (August 3, 1988)

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)
  • 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)