The following data is part of a premarket notification filed by V. Mueller Neuro/spine with the FDA for Psi Flexible Arm.
| Device ID | K942601 |
| 510k Number | K942601 |
| Device Name: | PSI FLEXIBLE ARM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | V. MUELLER NEURO/SPINE 871 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Terry Johnston |
| Correspondent | Terry Johnston V. MUELLER NEURO/SPINE 871 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-01 |
| Decision Date | 1994-12-27 |