JAR, COLLECTOR FOR SUCTION SYSTEMS— 510(k) K760333

Substantially Equivalent

Harris-Lake, Inc.

FDA 510(k) clearance K760333 for JAR, COLLECTOR FOR SUCTION SYSTEMS, Substantially Equivalent on 1976-10-27. Applicant: Harris-Lake, Inc..

Clearance details

Applicant
Harris-Lake, Inc.
Product code
Code GCX
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GCX

product code GCX
Death
9
Malfunction
592
Other
2
Total
603

Source: openFDA MAUDE database, through . 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.