The following data is part of a premarket notification filed by Serono, Inc. with the FDA for Clip-on Spacer 20%; 40%; 50%.
| Device ID | K041084 |
| 510k Number | K041084 |
| Device Name: | CLIP-ON SPACER 20%; 40%; 50% |
| Classification | Syringe, Piston |
| Applicant | SERONO, INC. ONE TECHNOLOGY PLACE Rockland, MA 02370 |
| Contact | Pamela Williamson Joyce |
| Correspondent | Pamela Williamson Joyce SERONO, INC. ONE TECHNOLOGY PLACE Rockland, MA 02370 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-07-15 |
| Summary: | summary |