The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Trach Care Start Kit.
| Device ID | K873732 |
| 510k Number | K873732 |
| Device Name: | TRACH CARE START KIT |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | BALLARD MEDICAL PRODUCTS 2101 L STREET, N.W. Washington, DC 20037 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein BALLARD MEDICAL PRODUCTS 2101 L STREET, N.W. Washington, DC 20037 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-10 |
| Decision Date | 1987-10-13 |