TYGON PAC-MONITORING LINES & FLUID ADMIN— 510(k) K770916

Substantially Equivalent

Norton Performance Plastics Corp.

FDA 510(k) clearance K770916 for TYGON PAC-MONITORING LINES & FLUID ADMIN, Substantially Equivalent on 1977-06-17. Applicant: Norton Performance Plastics Corp..

Clearance details

Applicant: Norton Performance Plastics Corp.
Product code: Code FMG
Advisory panel: General Hospital
Date received: 1977-05-19
Decision date: 1977-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.