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 |