K884978

Substantially Equivalent

PHARMA-PLAST INSULIN INFUSION SET

Applicant: Pharma-Plast USA, Inc.
Product code: LZG
Advisory panel: General Hospital
Date received: 1988-11-30
Decision date: 1989-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada H3a 2n4, CA

Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.