Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K090915 |
Device Name |
STERILE WATER FOR INHALATION FLEX BAG, USP |
Applicant |
CARDINAL HEALTH, INC. |
1430 WAUKEGAN ROAD- MPKB-2B |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
KIMBERLY SOUTHWELL |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DIVINE |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 04/01/2009 |
Decision Date | 11/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|