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510(k) K894505

COTOLIN DRAIN SPONGE AND DRESSING SPONGE by James River Corp. — Product Code EFQ

K894505 is an FDA 510(k) premarket notification submitted by James River Corp. for the device "COTOLIN DRAIN SPONGE AND DRESSING SPONGE". The FDA issued a decision of Substantially Equivalent on September 15, 1989. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. James River Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1989
Date Received
July 19, 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 James River Corp.

  • K894147 — VISULIN TRANSPARENT ADHESIVE DRESSING (August 9, 1989)
  • K893939 — ISOLATION MASKS (July 14, 1989)
  • K892580 — CARETOUCH EXAMINATION GLOVES (July 14, 1989)
  • K894034 — MODIFIED LABELING OF SURGICAL GLOVES (July 14, 1989)
  • K890459 — JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES (April 20, 1989)
  • K883802 — CARETEX CENTRAL SUPPLY WRAP (October 21, 1988)
  • K884112 — CARETEX OR TOWEL (October 13, 1988)
  • K883657 — SKID RESISTANT, LONG LASTING SHOE COVERS (September 15, 1988)
  • K880481 — CARETEX SURGEON'S CAPS (February 24, 1988)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 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)

FDA data resources