Home / 510(k) Clearances / K992005

510(k) K992005

GILTECH PLUS TRANSPARENT DRESSING by Giltech Plus, Inc. — Product Code MGP

K992005 is an FDA 510(k) premarket notification submitted by Giltech Plus, Inc. for the device "GILTECH PLUS TRANSPARENT DRESSING". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Giltech Plus, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1999
Date Received
June 15, 1999
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 Giltech Plus, Inc.

  • K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING (September 17, 1999)
  • K983624 — GILTECH PLUS CONNECTING TUBE SET (March 18, 1999)

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)
  • 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)
  • K983303 — INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSING (December 9, 1998)

FDA data resources