The following data is part of a premarket notification filed by Pointcore, Inc. with the FDA for Pointcore Surgical Mask.
Device ID | K220944 |
510k Number | K220944 |
Device Name: | PointCore Surgical Mask |
Classification | Mask, Surgical |
Applicant | PointCore, Inc. 124 SW Adams Peoria, IL 61602 |
Contact | William Christiansen |
Correspondent | Dave McGurl MCRA, LLC 803 7th Street, NW, 3rd Floor Washington, DC 20001 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-31 |
Decision Date | 2022-09-09 |