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510(k) K982234

AL-GEN CALCIUM ALGINATE DRESSING by Innovative Technologies , Ltd. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1998
Date Received
June 25, 1998
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)
  • 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)

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