Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K770356 |
Device Name |
ANESTHESIA KIT, EPIDURAL, SINGLE SHOT |
Applicant |
ARROW INTL., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ARROW INTL., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 02/22/1977 |
Decision Date | 03/01/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|