The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Trach Mask Model (245, 246).
| Device ID | K955483 |
| 510k Number | K955483 |
| Device Name: | TRACH MASK MODEL (245, 246) |
| Classification | Mask, Oxygen, Low Concentration, Venturi |
| Applicant | HOSPITAK, INC. 10 DANIEL ST. Farmingdale, NY 11735 |
| Contact | William Lacey |
| Correspondent | William Lacey HOSPITAK, INC. 10 DANIEL ST. Farmingdale, NY 11735 |
| Product Code | BYF |
| CFR Regulation Number | 868.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1996-02-28 |