The following data is part of a premarket notification filed by Physio Systems, Inc. with the FDA for Villan (video Lift Link Analysis).
| Device ID | K910712 |
| 510k Number | K910712 |
| Device Name: | VILLAN (VIDEO LIFT LINK ANALYSIS) |
| Classification | Guide, Drill, Ligament |
| Applicant | PHYSIO SYSTEMS, INC. 4450 ENTERPRISE ST. STE 101 Fremont, CA 94538 |
| Contact | David E Leiberman |
| Correspondent | David E Leiberman PHYSIO SYSTEMS, INC. 4450 ENTERPRISE ST. STE 101 Fremont, CA 94538 |
| Product Code | LXI |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-20 |
| Decision Date | 1991-05-21 |