The following data is part of a premarket notification filed by Twin Star Medical, Inc. with the FDA for Twin Star Compartment Pressure Monitor And Fluid Collection Catheter System (cms-ii).
| Device ID | K090961 |
| 510k Number | K090961 |
| Device Name: | TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | TWIN STAR MEDICAL, INC. 5116 BIRCH RD. Minnetonka, MN 55345 |
| Contact | Gregory W Sachs |
| Correspondent | Gregory W Sachs TWIN STAR MEDICAL, INC. 5116 BIRCH RD. Minnetonka, MN 55345 |
| Product Code | LXC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2009-06-12 |
| Summary: | summary |