The following data is part of a premarket notification filed by V. Mueller Neuro/spine with the FDA for Psi Titanium Micro-ligation Hemostatic Clip.
| Device ID | K991002 |
| 510k Number | K991002 |
| Device Name: | PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP |
| Classification | Clip, Implantable |
| Applicant | V. MUELLER NEURO/SPINE 360 INDUSTRIAL RD., UNIT H San Carlos, CA 94070 |
| Contact | Terry Johnston |
| Correspondent | Terry Johnston V. MUELLER NEURO/SPINE 360 INDUSTRIAL RD., UNIT H San Carlos, CA 94070 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-25 |
| Decision Date | 1999-06-11 |
| Summary: | summary |