Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K943319 |
Device Name |
GERTIE MARX EPI-SPINAL 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 | 07/11/1994 |
Decision Date | 06/30/1995 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|