The following data is part of a premarket notification filed by Wmi Enterprises Llc with the FDA for Wmi Reprocessed Dvt Wrap, Wmi Reprocessed Thermal Wrap Model: Rd-1000f, Rd-1000c, Rt 2000a, Rt 2000b, Rt 2000kf, Rt 2000.
| Device ID | K101035 |
| 510k Number | K101035 |
| Device Name: | WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | WMI ENTERPRISES LLC 1017 W. WASHINGTON, 2J Chicago, IL 60607 |
| Contact | Mike Wilford |
| Correspondent | Mike Wilford WMI ENTERPRISES LLC 1017 W. WASHINGTON, 2J Chicago, IL 60607 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2010-10-29 |