The following data is part of a premarket notification filed by Premiumestore, Llc with the FDA for Amerishield Surgical Mask.
| Device ID | K211520 |
| 510k Number | K211520 |
| Device Name: | Amerishield Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | PremiumEStore, LLC 2601 Reliance Drive Suite 102 Virginia Beach, VA 23452 |
| Contact | Brent Dillie |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-05-17 |
| Decision Date | 2021-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860004941917 | K211520 | 000 |
| 00860004941910 | K211520 | 000 |