The following data is part of a premarket notification filed by Ciba-geigy Corp. with the FDA for Brethancer, Drug Delivery Sys-inhal.
| Device ID | K833922 |
| 510k Number | K833922 |
| Device Name: | BRETHANCER, DRUG DELIVERY SYS-INHAL |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | CIBA-GEIGY CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-14 |
| Decision Date | 1983-12-08 |