Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K861401 |
Device Name |
LAERDAL POCKET MASK |
Applicant |
LAERDAL MEDICAL CORP. |
P.O. BOX 190, ONE LABRIOLA CT. |
ARMONK,
NY
10504
|
|
Applicant Contact |
RONALD L WEYHRAUCH |
Correspondent |
LAERDAL MEDICAL CORP. |
P.O. BOX 190, ONE LABRIOLA CT. |
ARMONK,
NY
10504
|
|
Correspondent Contact |
RONALD L WEYHRAUCH |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 04/15/1986 |
Decision Date | 05/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|