Device Classification Name |
mask, oxygen, non-rebreathing
|
510(k) Number |
K941336 |
Device Name |
COMBO MASK |
Applicant |
GAM INDUSTRIES, INC. |
P.O. BOX 2226 |
PETERSBURG,
VA
23804 -1526
|
|
Applicant Contact |
GARY J BEDEN |
Correspondent |
GAM INDUSTRIES, INC. |
P.O. BOX 2226 |
PETERSBURG,
VA
23804 -1526
|
|
Correspondent Contact |
GARY J BEDEN |
Regulation Number | 868.5570
|
Classification Product Code |
|
Date Received | 03/21/1994 |
Decision Date | 09/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|