The following data is part of a premarket notification filed by String King Lacrosse, Llc with the FDA for Surgical Mask - Level 3 - Blue - 50 Pcs, Surgical Mask - Level 3 - White - 50 Pcs, Procedure Mask - Level 3 - Blue - 50 Pcs, Procedure Mask - Level 3 - White - 50 Pcs.
| Device ID | K202607 |
| 510k Number | K202607 |
| Device Name: | Surgical Mask - Level 3 - Blue - 50 Pcs, Surgical Mask - Level 3 - White - 50 Pcs, Procedure Mask - Level 3 - Blue - 50 Pcs, Procedure Mask - Level 3 - White - 50 Pcs |
| Classification | Mask, Surgical |
| Applicant | String King Lacrosse, LLC 19100 S Vermont Ave. Gardena, CA 90248 |
| Contact | Thomas Frasca |
| Correspondent | Robert V. Packard Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-09 |
| Decision Date | 2021-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30195376202224 | K202607 | 000 |
| 30195376202217 | K202607 | 000 |
| 30195376202675 | K202607 | 000 |
| 30195376202668 | K202607 | 000 |