Device Classification Name |
Tent, Oxygen
|
510(k) Number |
K896608 |
Device Name |
SPAG PAK |
Applicant |
VIRATEK, INC. |
ICN PLAZA |
3300 HYLAND AVENUE |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
ALICE M WEI |
Correspondent |
VIRATEK, INC. |
ICN PLAZA |
3300 HYLAND AVENUE |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
ALICE M WEI |
Regulation Number | 868.5700
|
Classification Product Code |
|
Date Received | 11/21/1989 |
Decision Date | 04/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|