Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K111246 |
Device Name |
SPIRALE DRUG DELIVERY SYSTEM |
Applicant |
ARMSTRONG MEDICAL LTD. |
WATTSTOWN BUSINESS PARK |
NEWBRIDGE RD. |
COLERAINE,
IE
BT52 1BS
|
|
Applicant Contact |
IAN STEWART |
Correspondent |
ARMSTRONG MEDICAL LTD. |
WATTSTOWN BUSINESS PARK |
NEWBRIDGE RD. |
COLERAINE,
IE
BT52 1BS
|
|
Correspondent Contact |
IAN STEWART |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/04/2011 |
Decision Date | 08/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|