MONOJECT INJECTOMATIC— 510(k) K832683

Substantially Equivalent

Sherwood Medical Co.

FDA 510(k) clearance K832683 for MONOJECT INJECTOMATIC, Substantially Equivalent on 1983-09-12. Applicant: Sherwood Medical Co..

Clearance details

Applicant: Sherwood Medical Co.
Product code: Code KZH
Advisory panel: General Hospital
Date received: 1983-08-09
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.