The following data is part of a premarket notification filed by Premier Guard Usa Llc with the FDA for Premier Guard Usa 3 Layer Ear Loop Astm Level 3 Surgical Face Mask.
| Device ID | K202595 |
| 510k Number | K202595 |
| Device Name: | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Premier Guard USA LLC 406 Briarwood Drive Suite 400 Jackson, MS 39206 |
| Contact | Howard Sherman |
| Correspondent | Valerie Followell Followell Compliance Consultants LLC 8049 Tripp Ave Skokie, IL 60076 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2021-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850019294156 | K202595 | 000 |
| 00850019294002 | K202595 | 000 |
| 20850019294006 | K202595 | 000 |
| 10850019294016 | K202595 | 000 |
| 00850019294026 | K202595 | 000 |
| 00850019294019 | K202595 | 000 |