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510(k) K942824

LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S by Lorrex Health Products — Product Code EFQ

K942824 is an FDA 510(k) premarket notification submitted by Lorrex Health Products for the device "LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S". The FDA issued a decision of Substantially Equivalent on August 3, 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
August 3, 1994
Date Received
June 14, 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)
  • K945332 — ROSEBUD DISSECTOR (December 5, 1994)
  • K945336 — PEANUT DISSECTOR (December 5, 1994)
  • K945334 — CHERRY PIT DISSECTOR (December 5, 1994)
  • K942314 — LORREX GAUZE SPONGES SPECIALTY (June 2, 1994)
  • K942366 — LORREX GAUZE SPONGES, X-RAY DETECTABLE (May 27, 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