The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Serono For Use With Gonal-f 1200iu Multi-dose Only At 600iu/ml Syringe.
| Device ID | K003571 |
| 510k Number | K003571 |
| Device Name: | SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE |
| Classification | Syringe, Piston |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Barbara Smith |
| Correspondent | Barbara Smith TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-02-12 |