IMPACT, MODELS 306/307— 510(k) K820338

Substantially Equivalent

Impact Instrumentation, Inc.

FDA 510(k) clearance K820338 for IMPACT, MODELS 306/307, Substantially Equivalent on 1982-03-02. Applicant: Impact Instrumentation, Inc..

Clearance details

Applicant: Impact Instrumentation, Inc.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1982-02-08
Decision date: 1982-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.