The following data is part of a premarket notification filed by Pointcore, Inc. with the FDA for Pointcore Surgical Mask.
|Device Name:||PointCore Surgical Mask|
|Applicant||PointCore, Inc. 124 SW Adams Peoria, IL 61602|
MCRA, LLC 803 7th Street, NW, 3rd Floor Washington, DC 20001
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|