Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K023602 |
Device Name |
SMALL VOLUME NEBULIZER |
Applicant |
ALLEGIANCE HEALTHCARE CORPORATION |
1500 WAUKEGAN RD., BLDG. WM |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
SHARON NICHOLS |
Correspondent |
ALLEGIANCE HEALTHCARE CORPORATION |
1500 WAUKEGAN RD., BLDG. WM |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
SHARON NICHOLS |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 10/28/2002 |
Decision Date | 05/01/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|