IT HYDROCOLLOID WITH ZINC— 510(k) K973855
Substantially Equivalent for Some IndicationsInnovative Technologies , Ltd.
FDA 510(k) clearance K973855 for IT HYDROCOLLOID WITH ZINC, Substantially Equivalent for Some Indications on 1997-12-01. Applicant: Innovative Technologies , Ltd.. Device class: Unclassified.
Clearance details
- Applicant
- Innovative Technologies , Ltd.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Winsford, Cheshire, GB
Recent devices under product code FRO
view allMore clearances from Innovative Technologies , Ltd.
view all- K983303 — INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS
- K982234 — AL-GEN CALCIUM ALGINATE DRESSING
- K982638 — 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214
- K981753 — INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING
- K980989 — 3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.