PISTORMATIC— 510(k) K790104

Substantially Equivalent

Zelby, Burstein, Hartman & Burstein

FDA 510(k) clearance K790104 for PISTORMATIC, Substantially Equivalent on 1979-05-14. Applicant: Zelby, Burstein, Hartman & Burstein.

Clearance details

Applicant: Zelby, Burstein, Hartman & Burstein
Product code: Code KZH
Advisory panel: General Hospital
Date received: 1979-01-16
Decision date: 1979-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.