The following data is part of a premarket notification filed by Travenol Laboratories (israel) Ltd. with the FDA for Copaxone (copolymer-1 For Injection) Self-injection Administration Package.
| Device ID | K964060 |
| 510k Number | K964060 |
| Device Name: | COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE |
| Classification | Syringe, Piston |
| Applicant | TRAVENOL LABORATORIES (ISRAEL) LTD. INDUSTRIAL ZONE Kiriat Shmona, IL |
| Contact | Harry Leinwand |
| Correspondent | Harry Leinwand TRAVENOL LABORATORIES (ISRAEL) LTD. INDUSTRIAL ZONE Kiriat Shmona, IL |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-09 |
| Decision Date | 1996-12-24 |