MUCOTROL CONCENTRATED ORAL GEL WAFER— 510(k) K042400

Name: FDA 510(k) clearance K042400
Creator: U.S. Food and Drug Administration
Published: 2004-11-24

Substantially Equivalent

Belcher Pharmaceuticals, Inc.

FDA 510(k) clearance K042400 for MUCOTROL CONCENTRATED ORAL GEL WAFER, Substantially Equivalent on 2004-11-24. Applicant: Belcher Pharmaceuticals, Inc.. Device class: Unclassified.

Clearance details

Applicant: Belcher Pharmaceuticals, Inc.
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2004-09-03
Decision date: 2004-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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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.