Home / 510(k) Clearances / K910623

510(k) K910623

GAUZE SPONGES ABSORBENT GAUZE ROLLS by Liaoning-Usa Corp. — Product Code EFQ

K910623 is an FDA 510(k) premarket notification submitted by Liaoning-Usa Corp. for the device "GAUZE SPONGES ABSORBENT GAUZE ROLLS". The FDA issued a decision of Substantially Equivalent on April 1, 1991. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Liaoning-Usa Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1991
Date Received
February 13, 1991
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 Liaoning-Usa Corp.

  • K911921 — DISPOSABLE ISOLATION GOWN (May 13, 1991)
  • K905487 — VARIOUS TYPES OF STETHOSCOPES (April 9, 1991)
  • K902625 — CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT (October 26, 1990)
  • K892781 — ANTELOPE BRAND PATIENT EXAMINATION GLOVES (September 21, 1989)
  • K892774 — PATIENT EXAMINATION GLOVES (September 13, 1989)

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