PRIMOSPLINT SYSTEM— 510(k) K030832

Name: FDA 510(k) clearance K030832
Creator: U.S. Food and Drug Administration
Published: 2003-09-17

Substantially Equivalent

Cosmedent, Inc.

FDA 510(k) clearance K030832 for PRIMOSPLINT SYSTEM, Substantially Equivalent on 2003-09-17. Applicant: Cosmedent, Inc.. Device class: Unclassified.

Clearance details

Applicant: Cosmedent, Inc.
Product code: Code MQC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2003-03-17
Decision date: 2003-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.