Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K941493 |
Device Name |
KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT |
Applicant |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
DEAN E CIPORKIN |
Correspondent |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
DEAN E CIPORKIN |
Regulation Number | 868.5140
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/28/1994 |
Decision Date | 06/22/1994 |
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
|