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 |