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510(k) K940754

ISOLYER (4X4, 12 PLY) by Thantex Specialties, Inc. — Product Code EFQ

K940754 is an FDA 510(k) premarket notification submitted by Thantex Specialties, Inc. for the device "ISOLYER (4X4, 12 PLY)". The FDA issued a decision of Substantially Equivalent on May 2, 1994. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Thantex Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1994
Date Received
Feb 18, 1994
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 Thantex Specialties, Inc.

  • K970547 — ISOLYSER SDS SHARPS CONTAINER (Jul 18, 1997)
  • K961083 — OREX SURGEON'S VEST (Aug 23, 1996)
  • K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (Aug 7, 1995)
  • K943626 — ISOLYSER SHARPS MANAGEMENT SYSTEM SMS (Jun 16, 1995)
  • K945755 — OREX(R) O.R EQUIPMENT DRAPES (May 25, 1995)
  • K945223 — OREX ISOLATION GOWN (Apr 25, 1995)
  • K944827 — OREX SURGEON'S GOWN (Feb 28, 1995)
  • K944859 — OREX SURGICAL DRAPES (Feb 28, 1995)
  • K943034 — OREX SHOE COVERS (Jan 2, 1995)
  • K942228 — OREX O.R. TOWEL (Dec 20, 1994)

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