Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K880181 |
Device Name |
REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY |
Applicant |
REGANES, INC. |
P.O. BOX 13212 |
CLEARWATER,
FL
33519
|
|
Applicant Contact |
JOSEPH E HARMS |
Correspondent |
REGANES, INC. |
P.O. BOX 13212 |
CLEARWATER,
FL
33519
|
|
Correspondent Contact |
JOSEPH E HARMS |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 01/15/1988 |
Decision Date | 02/11/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|