The following data is part of a premarket notification filed by Sawbros Industries Pvt.ltd. with the FDA for Reverse Pull Adjustable Facemask.
| Device ID | K162543 |
| 510k Number | K162543 |
| Device Name: | Reverse Pull Adjustable Facemask |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | SAWBROS INDUSTRIES PVT.LTD. A-68 SECTOR 2 Noida, IN 201301 |
| Contact | Dhruv Sawhney |
| Correspondent | Dhruv Sawhney SAWBROS INDUSTRIES PVT.LTD. A-68 SECTOR 2 Noida, IN 201301 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-12 |
| Decision Date | 2017-08-28 |