ACCU-BITE HOME KIT DISCLUDER— 510(k) K980953

Substantially Equivalent

Jerome M. Simon

FDA 510(k) clearance K980953 for ACCU-BITE HOME KIT DISCLUDER, Substantially Equivalent on 1998-10-07. Applicant: Jerome M. Simon.

Clearance details

Applicant: Jerome M. Simon
Product code: Code MQC
Advisory panel: Unknown
Date received: 1998-03-13
Decision date: 1998-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, 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.