The following data is part of a premarket notification filed by Topspins, Inc. with the FDA for Mri Compatible Thigh Tourniquet, Model C070002.
| Device ID | K071140 |
| 510k Number | K071140 |
| Device Name: | MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 |
| Classification | Tourniquet, Pneumatic |
| Applicant | TOPSPINS, INC. 403 RIVERVIEW DR Ann Arbor, MI 48107 -7205 |
| Contact | Erin Buethe |
| Correspondent | Erin Buethe TOPSPINS, INC. 403 RIVERVIEW DR Ann Arbor, MI 48107 -7205 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-24 |
| Decision Date | 2007-06-07 |