LOWENSTEIN-JENSEN, GRUFT— 510(k) K880131

Substantially Equivalent

Hardy Media

FDA 510(k) clearance K880131 for LOWENSTEIN-JENSEN, GRUFT, Substantially Equivalent on 1988-03-31. Applicant: Hardy Media.

Clearance details

Applicant: Hardy Media
Product code: Code KZI
Advisory panel: Microbiology
Date received: 1988-01-06
Decision date: 1988-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZI

product code KZI

Malfunction: 2,834
Total: 2,834

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.