EXMOOR BITE BUFFER— 510(k) K893006

Substantially Equivalent

Exmoor Plastics , Ltd.

FDA 510(k) clearance K893006 for EXMOOR BITE BUFFER, Substantially Equivalent on 1990-03-05. Applicant: Exmoor Plastics , Ltd..

Clearance details

Applicant: Exmoor Plastics , Ltd.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 1989-04-24
Decision date: 1990-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.