The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Ivs Clip Closure System, Model 1002 (ivs Clip Applier), 14677.
| Device ID | K051125 |
| 510k Number | K051125 |
| Device Name: | IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 |
| Classification | Clip, Implantable |
| Applicant | ABBOTT LABORATORIES 400 Saginaw Drive Redwood City, CA 94063 |
| Contact | Kim Smith-servance |
| Correspondent | Kim Smith-servance ABBOTT LABORATORIES 400 Saginaw Drive Redwood City, CA 94063 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-03 |
| Decision Date | 2005-06-08 |
| Summary: | summary |