The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Trach Care Mdi Adapter.
| Device ID | K900273 |
| 510k Number | K900273 |
| Device Name: | TRACH CARE MDI ADAPTER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Martin Chamberlain |
| Correspondent | Martin Chamberlain BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-19 |
| Decision Date | 1990-08-29 |