The following data is part of a premarket notification filed by Secured Ortho Manufacturing Of America, Llc with the FDA for Secure Wear Usa Surgical Face Mask.
Device ID | K203101 |
510k Number | K203101 |
Device Name: | Secure Wear USA Surgical Face Mask |
Classification | Mask, Surgical |
Applicant | Secured Ortho Manufacturing Of America, LLC 28 West Jefryn Boulevard Suite C Deer Park, NY 11729 |
Contact | Vincent Benenati |
Correspondent | Vincent Benenati Secured Ortho Manufacturing Of America, LLC 28 West Jefryn Boulevard Suite C Deer Park, NY 11729 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-10-14 |
Decision Date | 2021-03-31 |