Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K780406 |
Device Name |
2C7153 NEBULIZER CAP |
Applicant |
TRAVENOL LABORATORIES, S.A. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
TRAVENOL LABORATORIES, S.A. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 03/13/1978 |
Decision Date | 04/12/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|