Home / 510(k) Clearances / K974347

510(k) K974347

BALDUR NON-STERILE COTTON SPONGES by Baldur Systems Corp. — Product Code EFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1998
Date Received
November 19, 1997
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 Baldur Systems Corp.

  • K981823 — OPERATING ROOM TOWELS (August 11, 1998)
  • K892684 — PATIENT EXAMINATION GLOVES (LATEX) (September 11, 1989)
  • K891728 — LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) (May 25, 1989)
  • K891727 — LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD) (May 12, 1989)
  • K891726 — VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) (May 12, 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)