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510(k) K941955

LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S by Lorrex Health Products — Product Code EFQ

K941955 is an FDA 510(k) premarket notification submitted by Lorrex Health Products for the device "LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S". The FDA issued a decision of Substantially Equivalent on May 12, 1994. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Lorrex Health Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1994
Date Received
April 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Lorrex Health Products

  • K945553 — ROUND STICK SPONGES, FLAT STICK SPONGES (December 28, 1994)
  • K945606 — TRIANGULAR SPONGES (December 28, 1994)
  • K945333 — KITTNER DISSECTOR (December 28, 1994)
  • K945866 — CYLINDRICAL SPONGE (December 28, 1994)
  • K945335 — CHERRY DISSECTOR (December 28, 1994)
  • K945334 — CHERRY PIT DISSECTOR (December 5, 1994)
  • K945332 — ROSEBUD DISSECTOR (December 5, 1994)
  • K945336 — PEANUT 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)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources