REXASTOM ORAL EASE— 510(k) K082553

Substantially Equivalent

Rexaderm, Inc.

FDA 510(k) clearance K082553 for REXASTOM ORAL EASE, Substantially Equivalent on 2008-11-21. Applicant: Rexaderm, Inc..

Clearance details

Applicant: Rexaderm, Inc.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2008-09-03
Decision date: 2008-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, 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.