The following data is part of a premarket notification filed by Wmi Enterprises Llc with the FDA for Wmi Dvt Wrap, Wmi Thermal Wrap Model: D-1000f, D-1000c, T-2000a, T-2000b, T-2000kf, T-2000s, T-2000n.
Device ID | K100969 |
510k Number | K100969 |
Device Name: | WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N |
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 | 2010-04-08 |
Decision Date | 2010-09-20 |
Summary: | summary |