MITRAFLEX PIGMENTED WOUND DRESSING— 510(k) K964701

Substantially Equivalent

Polymedica Industries, Inc.

FDA 510(k) clearance K964701 for MITRAFLEX PIGMENTED WOUND DRESSING, Substantially Equivalent on 1997-02-07. Applicant: Polymedica Industries, Inc..

Clearance details

Applicant: Polymedica Industries, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1996-11-25
Decision date: 1997-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden,, CO, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.