Device Classification Name |
Airway, Oropharyngeal, Anesthesiology
|
510(k) Number |
K922748 |
Device Name |
GUEDEL AIRWAY |
Applicant |
OEM MEDICAL DIV. |
8741 LANDMARK RD. |
P.O. BOX 27604 |
RICHMOND,
VA
23228
|
|
Applicant Contact |
JERRY W.SCHEIB |
Correspondent |
OEM MEDICAL DIV. |
8741 LANDMARK RD. |
P.O. BOX 27604 |
RICHMOND,
VA
23228
|
|
Correspondent Contact |
JERRY W.SCHEIB |
Regulation Number | 868.5110
|
Classification Product Code |
|
Date Received | 06/08/1992 |
Decision Date | 07/10/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|