The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Surgifresh Sub-micron Mask No. 901008-000.
| Device ID | K893417 |
| 510k Number | K893417 |
| Device Name: | SURGIFRESH SUB-MICRON MASK NO. 901008-000 |
| Classification | Mask, Surgical |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 2828 N.CRESCENT RIDGE DR. The Woodlands, TX 77381 |
| Contact | Roger Mogill |
| Correspondent | Roger Mogill TEXAS MEDICAL PRODUCTS, INC. 2828 N.CRESCENT RIDGE DR. The Woodlands, TX 77381 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-02 |
| Decision Date | 1989-06-22 |