The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Bronchitrac.
| Device ID | K822398 |
| 510k Number | K822398 |
| Device Name: | ACKRAD BRONCHITRAC |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | ACKRAD LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-10 |
| Decision Date | 1982-10-04 |