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510(k) K882710

INTESTINAL SPONGES by Bioseal — Product Code EFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1988
Date Received
June 27, 1988
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 Bioseal

  • K893814 — SURGICAL INSTRUMENT KIT, DISPOSABLE (August 10, 1989)
  • K882695 — RUBBER BAND, STERILE (October 13, 1988)
  • K882696 — DERMICEL, MONTGOMERY STRAP (August 26, 1988)
  • K882694 — FIXATION DEVICE, TRACH TUBE (August 15, 1988)
  • K882708 — GAUZE SPONGE, X-RAY DETECTABLE (August 3, 1988)
  • K882711 — GAUZE SPONGE 12PLY (August 3, 1988)
  • K882707 — GAUZE PACKING, X-RAY DETECTABLE (August 3, 1988)
  • K882712 — STICK SPONGE (August 3, 1988)
  • K882709 — TONSIL SPONGE, X-RAY DETECTABLE, W/STRING (August 3, 1988)

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)