NORMLGEL PROTECTIVE WOUND GEL— 510(k) K905438

Substantially Equivalent

Scott Health Care

FDA 510(k) clearance K905438 for NORMLGEL PROTECTIVE WOUND GEL, Substantially Equivalent on 1991-04-01. Applicant: Scott Health Care.

Clearance details

Applicant: Scott Health Care
Product code: Code FRO
Advisory panel: Unknown
Date received: 1990-12-04
Decision date: 1991-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, 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.