The following data is part of a premarket notification filed by Defender Safety Inc. with the FDA for Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3.
| Device ID | K210705 |
| 510k Number | K210705 |
| Device Name: | Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 |
| Classification | Mask, Surgical |
| Applicant | Defender Safety Inc. 30 Skyline Drive Plainview, NY 11803 |
| Contact | Nahal Islam |
| Correspondent | Nahal Islam Defender Safety Inc. 30 Skyline Drive Plainview, NY 11803 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-09 |
| Decision Date | 2021-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007209536 | K210705 | 000 |
| 00860007209529 | K210705 | 000 |
| 00860007209505 | K210705 | 000 |