Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K833922 |
Device Name |
BRETHANCER, DRUG DELIVERY SYS-INHAL |
Applicant |
CIBA-GEIGY CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
CIBA-GEIGY CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 11/14/1983 |
Decision Date | 12/08/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|