The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd with the FDA for Woundexpress.
Device ID | K211200 |
510k Number | K211200 |
Device Name: | WoundExpress |
Classification | Sleeve, Limb, Compressible |
Applicant | Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
Contact | Steve Monks |
Correspondent | Steve Monks Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-22 |
Decision Date | 2021-09-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WOUNDEXPRESS 79325256 not registered Live/Pending |
Arjo IP Holding AB 2021-09-27 |