The following data is part of a premarket notification filed by Wildcat Ppe, Llc with the FDA for Wildcat Pe Surgical Isolation Gown Open Back, Wildcat Pe Surgical Isolation Gown Full Back.
|Device Name:||Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back|
|Classification||Gown, Isolation, Surgical|
|Applicant||Wildcat PPE, LLC 301 S. Trade Center Pkwy Conroe, TX 77385|
Wildcat PPE, LLC 301 S. Trade Center Pkwy Conroe, TX 77385
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|