Device Classification Name |
labor and delivery kit
|
510(k) Number |
K960243 |
Device Name |
CPR C-SECTION DELIVERY PACK |
Applicant |
CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 |
ORLANDO,
FL
32811
|
|
Applicant Contact |
RICHARD L ELLWOOD |
Correspondent |
CUSTOM PACK RELIABILITY |
4207 VINELAND ROAD, M-1 |
ORLANDO,
FL
32811
|
|
Correspondent Contact |
RICHARD L ELLWOOD |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 01/16/1996 |
Decision Date | 05/23/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|