Home / 510(k) Clearances / K895086

510(k) K895086

GAUZE SPONGE by Keilei Intl., Inc. — Product Code EFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1989
Date Received
August 8, 1989
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 Keilei Intl., Inc.

  • K913779 — BANDAGE ROLL, GAUZE (December 4, 1991)
  • K912779 — GAUZE SPONGE,STERILE 2'S (September 30, 1991)
  • K913575 — GAUZE PACKING, SURGICAL STERILE AND NON-STERILE (September 6, 1991)
  • K895372 — X-RAY DETECTABLE GAUZE SPONGE (November 3, 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)