The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Surgical Face Mask-disposable.
| Device ID | K832194 |
| 510k Number | K832194 |
| Device Name: | SURGICAL FACE MASK-DISPOSABLE |
| Classification | Mask, Surgical |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-08 |
| Decision Date | 1983-07-26 |