The following data is part of a premarket notification filed by Protect U Guard, Llc with the FDA for Protect U Guard Earloop And Tie-on Mask (blue, White Or Green).
| Device ID | K153409 |
| 510k Number | K153409 |
| Device Name: | Protect U Guard Earloop And Tie-On Mask (Blue, White Or Green) |
| Classification | Mask, Surgical |
| Applicant | PROTECT U GUARD, LLC 1840 MEASE DRIVE SUITE 319 Safety Harbor, FL 34695 |
| Contact | Brent W. Laartz |
| Correspondent | Brent W. Laartz PROTECT U GUARD, LLC 1840 MEASE DRIVE SUITE 319 Safety Harbor, FL 34695 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B086200432 | K153409 | 000 |
| B086100321 | K153409 | 000 |
| B086100331 | K153409 | 000 |
| B086100411 | K153409 | 000 |
| B086100421 | K153409 | 000 |
| B086100431 | K153409 | 000 |
| B086200312 | K153409 | 000 |
| B086200322 | K153409 | 000 |
| B086200332 | K153409 | 000 |
| B086200412 | K153409 | 000 |
| B086200422 | K153409 | 000 |
| B086100311 | K153409 | 000 |