FREE FLOW SAFETY DEVICE, MODEL MG 245052— 510(k) K990288

Substantially Equivalent

Teva Medical, Ltd.

FDA 510(k) clearance K990288 for FREE FLOW SAFETY DEVICE, MODEL MG 245052, Substantially Equivalent on 1999-02-24. Applicant: Teva Medical, Ltd.. Device class: 2.

Clearance details

Applicant
Teva Medical, Ltd.
Product code
Code FPA
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood Cliffs, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FPA

product code FPA
Death
95
Injury
14,421
Malfunction
125,815
Other
30
Total
140,361

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.