FLEXIGEL-G HYDROGEL WOUND DRESSING— 510(k) K980097

Substantially Equivalent

Innovative Technologies , Ltd.

FDA 510(k) clearance K980097 for FLEXIGEL-G HYDROGEL WOUND DRESSING, Substantially Equivalent on 1998-03-04. Applicant: Innovative Technologies , Ltd.. Device class: Unclassified.

Clearance details

Applicant
Innovative Technologies , Ltd.
Product code
Code MGQ
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Winsford, Cheshire, GB
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MGQ

product code MGQ
Death
16
Total
16

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 →

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