Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K912445 |
Device Name |
MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT |
Applicant |
MEGA MEDICAL, INC. |
P.O. BOX 260956 |
TAMPA,
FL
33685
|
|
Applicant Contact |
ELLEN JOY |
Correspondent |
MEGA MEDICAL, INC. |
P.O. BOX 260956 |
TAMPA,
FL
33685
|
|
Correspondent Contact |
ELLEN JOY |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 06/03/1991 |
Decision Date | 10/18/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|