Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K871427 |
Device Name |
(SPAG) MODEL SPAG-2 6000 SERIES |
Applicant |
VIRATEK, INC. |
ICN PLAZA |
3300 HYLAND AVENUE |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
STAFFA, PHD |
Correspondent |
VIRATEK, INC. |
ICN PLAZA |
3300 HYLAND AVENUE |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
STAFFA, PHD |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 04/09/1987 |
Decision Date | 10/06/1987 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|