The following data is part of a premarket notification filed by W. Keith Thornton, D.d.s. with the FDA for Combination Toa With Nasal Mask Holder And Universal Nasal Mask Holder.
| Device ID | K981744 |
| 510k Number | K981744 |
| Device Name: | COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | W. KEITH THORNTON, D.D.S. 6131 LUTHER LANE, SUITE 208 Dallas, TX 75225 |
| Contact | W.keith Thornton |
| Correspondent | W.keith Thornton W. KEITH THORNTON, D.D.S. 6131 LUTHER LANE, SUITE 208 Dallas, TX 75225 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1998-10-14 |
| Summary: | summary |