Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K963917 |
Device Name |
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT |
Applicant |
HOLDEN WALKER CORP. |
4227 B ARNOLD AVE. |
P.O. BOX 8207 |
NAPLES,
FL
33941 -8207
|
|
Applicant Contact |
DONALD L RETALLICK, III |
Correspondent |
HOLDEN WALKER CORP. |
4227 B ARNOLD AVE. |
P.O. BOX 8207 |
NAPLES,
FL
33941 -8207
|
|
Correspondent Contact |
DONALD L RETALLICK, III |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/30/1996 |
Decision Date | 02/25/1997 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|