NIGHTGUARD DIAGNOSTIC APPLIANCE— 510(k) K955701

Substantially Equivalent

Cycura Corp.

FDA 510(k) clearance K955701 for NIGHTGUARD DIAGNOSTIC APPLIANCE, Substantially Equivalent on 1996-03-08. Applicant: Cycura Corp..

Clearance details

Applicant: Cycura Corp.
Product code: Code MQC
Advisory panel: Unknown
Date received: 1995-12-15
Decision date: 1996-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rocklin, CA, US

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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.