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510(k) K983303

INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS by Innovative Technologies , Ltd. — Product Code MGP

K983303 is an FDA 510(k) premarket notification submitted by Innovative Technologies , Ltd. for the device "INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS". The FDA issued a decision of Substantially Equivalent on December 9, 1998. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Innovative Technologies , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1998
Date Received
September 21, 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 Innovative Technologies , Ltd.

  • K982234 — AL-GEN CALCIUM ALGINATE DRESSING (September 8, 1998)
  • K982638 — 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90 (August 21, 1998)
  • K981753 — INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING (June 30, 1998)
  • K980989 — 3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING (May 27, 1998)
  • K980097 — FLEXIGEL-G HYDROGEL WOUND DRESSING (March 4, 1998)
  • K973855 — IT HYDROCOLLOID WITH ZINC (December 1, 1997)
  • K973312 — TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING (October 22, 1997)
  • K973283 — ALGINATE/ZINC WOUND DRESSING (October 21, 1997)
  • K971126 — HYDROCOLLOID WOUND DRESSINGS (June 24, 1997)
  • K963598 — INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS (November 27, 1996)

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