SILICONE BLOCK— 510(k) K042380

Substantially Equivalent

National Medical Devices, Inc.

FDA 510(k) clearance K042380 for SILICONE BLOCK, Substantially Equivalent on 2004-10-25. Applicant: National Medical Devices, Inc..

Clearance details

Applicant: National Medical Devices, Inc.
Product code: Code MIB
Advisory panel: Ear, Nose, Throat
Date received: 2004-09-01
Decision date: 2004-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, CA, US

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Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.