The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Trach Care Set With Microban.
| Device ID | K964369 |
| 510k Number | K964369 |
| Device Name: | TRACH CARE SET WITH MICROBAN |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Contact | E. Martin Chamberlain, Jr. |
| Correspondent | E. Martin Chamberlain, Jr. BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-02-11 |