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510(k) K945553

ROUND STICK SPONGES, FLAT STICK SPONGES by Lorrex Health Products — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1994
Date Received
November 10, 1994
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 Lorrex Health Products

  • K945606 — TRIANGULAR SPONGES (December 28, 1994)
  • K945335 — CHERRY DISSECTOR (December 28, 1994)
  • K945333 — KITTNER DISSECTOR (December 28, 1994)
  • K945866 — CYLINDRICAL SPONGE (December 28, 1994)
  • K945336 — PEANUT DISSECTOR (December 5, 1994)
  • K945332 — ROSEBUD DISSECTOR (December 5, 1994)
  • K945334 — CHERRY PIT DISSECTOR (December 5, 1994)
  • K942824 — LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S (August 3, 1994)
  • K942314 — LORREX GAUZE SPONGES SPECIALTY (June 2, 1994)
  • K942366 — LORREX GAUZE SPONGES, X-RAY DETECTABLE (May 27, 1994)

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)