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510(k) K831913

COLOR-EZE PRE-WASHED LAP SPONGES by Ormed Mfg., Inc. — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
June 14, 1983
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 Ormed Mfg., Inc.

  • K931555 — ARTROMOT K2 CPM (January 31, 1994)
  • K882528 — CYLINDRICAL SPONGE (July 18, 1988)
  • K882529 — BUTCHER STRUNG TONSIL SPONGE (July 18, 1988)
  • K882527 — GAUZE SPONGE (July 18, 1988)
  • K882530 — TAPE STRUNG TONSIL SPONGE (July 18, 1988)
  • K880907 — TRIANGLE SPONGE (March 17, 1988)
  • K880853 — CHERRY SPONGE (March 17, 1988)
  • K880909 — TRACHEOTOMY SPONGES (March 17, 1988)
  • K880851 — FLAT STICK SPONGE (March 17, 1988)
  • K880911 — BLUNT SPONGE (March 17, 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)
  • 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)