Home / 510(k) Clearances / K983234

510(k) K983234

TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING by Johnson & Johnson Medical, Div. of Ethicon, Inc. — Product Code MGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1998
Date Received
September 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Johnson & Johnson Medical, Div. of Ethicon, Inc.

  • K990236 — MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CA (August 20, 1999)
  • K990395 — BARRIER SURGICAL GOWNS (April 13, 1999)
  • K983240 — NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES (November 30, 1998)
  • K983394 — MODIFICATION TO TIELLE HYDROPOLMER DRESSING (November 3, 1998)

Other clearances for product code MGP

  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (March 3, 1999)