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510(k) K983394

MODIFICATION TO TIELLE HYDROPOLMER DRESSING by Johnson & Johnson Medical, Div. of Ethicon, Inc. — Product Code MGP

K983394 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Div. of Ethicon, Inc. for the device "MODIFICATION TO TIELLE HYDROPOLMER DRESSING". The FDA issued a decision of Substantially Equivalent on November 3, 1998. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Johnson & Johnson Medical, Div. of Ethicon, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1998
Date Received
September 25, 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)
  • K983234 — TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (November 25, 1998)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (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)

FDA data resources