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510(k) K974347

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

K974347 is an FDA 510(k) premarket notification submitted by Baldur Systems Corp. for the device "BALDUR NON-STERILE COTTON SPONGES". The FDA issued a decision of Substantially Equivalent on Feb 10, 1998. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Baldur Systems Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 10, 1998
Date Received
Nov 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 (Aug 11, 1998)
  • K892684 — PATIENT EXAMINATION GLOVES (LATEX) (Sep 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 (Aug 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (Jun 11, 1999)
  • K990974 — VITOP DRESSING (Jun 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (Apr 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (Feb 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (Feb 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (Dec 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (Nov 12, 1998)
  • K982648 — JOAN II (Sep 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (Apr 29, 1998)

FDA data resources