Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K935245 |
Device Name |
EPIDURAL ANESTHESIA TRAY |
Applicant |
SPINAL SPECIALTIES, INC. |
4230 CENTERGATE |
SAN ANTONIO,
TX
78217
|
|
Applicant Contact |
ROBERT KEAHEY |
Correspondent |
SPINAL SPECIALTIES, INC. |
4230 CENTERGATE |
SAN ANTONIO,
TX
78217
|
|
Correspondent Contact |
ROBERT KEAHEY |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 11/01/1993 |
Decision Date | 05/02/1994 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|