The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for 72 Hour Use Trach Care With Microban.
| Device ID | K974630 |
| 510k Number | K974630 |
| Device Name: | 72 HOUR USE TRACH CARE WITH MICROBAN |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-12 |
| Decision Date | 1998-03-11 |
| Summary: | summary |