Device Classification Name |
labor and delivery kit
|
510(k) Number |
K936120 |
Device Name |
LABOR AND DELIVERY TRAY |
Applicant |
CUSH MEDICAL PRODUCTS |
P.O. BOX 247 |
881 MOUNTAIN VIEW DRIVE |
PINEY FLATS,
TN
37686
|
|
Applicant Contact |
STEVE B JOHNSTON |
Correspondent |
CUSH MEDICAL PRODUCTS |
P.O. BOX 247 |
881 MOUNTAIN VIEW DRIVE |
PINEY FLATS,
TN
37686
|
|
Correspondent Contact |
STEVE B JOHNSTON |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 12/23/1993 |
Decision Date | 03/30/1994 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|