The following data is part of a premarket notification filed by Neurosel (medical) Limited with the FDA for Twister Superelastic Ligating Clip And Applier.
| Device ID | K032238 |
| 510k Number | K032238 |
| Device Name: | TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER |
| Classification | Clip, Implantable |
| Applicant | NEUROSEL (MEDICAL) LIMITED GREENWAYS ABBOTTS ANN Andover, Hampshire, GB Sp11 7bh |
| Contact | Peter Gibson |
| Correspondent | Peter Gibson NEUROSEL (MEDICAL) LIMITED GREENWAYS ABBOTTS ANN Andover, Hampshire, GB Sp11 7bh |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-09-09 |
| Summary: | summary |