The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for Terumo Syringe For Administration Of Uv Sensitive Medicines.
| Device ID | K053413 |
| 510k Number | K053413 |
| Device Name: | TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES |
| Classification | Syringe, Piston |
| Applicant | TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 Leuven, BE 3001 |
| Contact | M.j. Aerts |
| Correspondent | M.j. Aerts TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 Leuven, BE 3001 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-07 |
| Decision Date | 2006-04-06 |
| Summary: | summary |