The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for Syringe With Fixed Needle - For Use Only With Gonal-f Multi-dose 600 I/u Ml Fsh.
| Device ID | K161606 |
| 510k Number | K161606 |
| Device Name: | Syringe With Fixed Needle - For Use Only With GONAL-F Multi-Dose 600 I/U ML FSH |
| Classification | Syringe, Piston |
| Applicant | TERUMO EUROPE N.V. INTERLEUVENLAAN 40 Leuven, BE 3001 |
| Contact | M.j. Aerts |
| Correspondent | M.j. Aerts TERUMO EUROPE N.V. 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 | Yes |
| Date Received | 2016-06-10 |
| Decision Date | 2017-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55413206220248 | K161606 | 000 |
| 55413206214209 | K161606 | 000 |
| 55413206214162 | K161606 | 000 |