Device Classification Name |
resuscitator, manual, non self-inflating
|
510(k) Number |
K013308 |
Device Name |
VENTLAB HYPERINFLATION BAG SYSTEM |
Applicant |
VENTLAB CORP. |
2934 HWY. 601 NORTH |
MOCKSVILLE,
NC
27028
|
|
Applicant Contact |
MARGE WALLS-WALKER |
Correspondent |
VENTLAB CORP. |
2934 HWY. 601 NORTH |
MOCKSVILLE,
NC
27028
|
|
Correspondent Contact |
MARGE WALLS-WALKER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 10/04/2001 |
Decision Date | 12/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|