CARAPASTE ORAL WOUND DRESSING— 510(k) K082856

Substantially Equivalent

Mcgrath Pharmaceuticals, Inc.

FDA 510(k) clearance K082856 for CARAPASTE ORAL WOUND DRESSING, Substantially Equivalent on 2008-10-15. Applicant: Mcgrath Pharmaceuticals, Inc..

Clearance details

Applicant: Mcgrath Pharmaceuticals, Inc.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2008-09-29
Decision date: 2008-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grayslake, IL, US

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Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

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.