ADD-A-VIAL— 510(k) K904855

Substantially Equivalent

Kendall Mcgaw Laboratories, Inc.

FDA 510(k) clearance K904855 for ADD-A-VIAL, Substantially Equivalent on 1990-11-19. Applicant: Kendall Mcgaw Laboratories, Inc..

Clearance details

Applicant: Kendall Mcgaw Laboratories, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1990-10-29
Decision date: 1990-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.