COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE— 510(k) K964060

Substantially Equivalent

Travenol Laboratories (Israel) , Ltd.

FDA 510(k) clearance K964060 for COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE, Substantially Equivalent on 1996-12-24. Applicant: Travenol Laboratories (Israel) , Ltd..

Clearance details

Applicant: Travenol Laboratories (Israel) , Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1996-10-09
Decision date: 1996-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kiriat Shemona, IL

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.