The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for High Filtration Iso-mask.
| Device ID | K831148 |
| 510k Number | K831148 |
| Device Name: | HIGH FILTRATION ISO-MASK |
| Classification | Mask, Surgical |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-08 |
| Decision Date | 1984-07-17 |