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510(k) K963598

INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS by Innovative Technologies , Ltd. — Product Code KMF

K963598 is an FDA 510(k) premarket notification submitted by Innovative Technologies , Ltd. for the device "INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS". The FDA issued a decision of Substantially Equivalent on November 27, 1996. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Innovative Technologies , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1996
Date Received
September 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Innovative Technologies , Ltd.

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

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)

FDA data resources