Device Classification Name |
catheter, umbilical artery
|
510(k) Number |
K963972 |
Device Name |
NEO-CARE DUAL LUMEN UMBILICAL CATHETER |
Applicant |
KLEIN-BAKER MEDICAL, INC. |
12001 NETWORK, SUITE 110 |
SAN ANTONIO,
TX
78249
|
|
Applicant Contact |
CLYDE N BAKER |
Correspondent |
KLEIN-BAKER MEDICAL, INC. |
12001 NETWORK, SUITE 110 |
SAN ANTONIO,
TX
78249
|
|
Correspondent Contact |
CLYDE N BAKER |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 10/03/1996 |
Decision Date | 12/24/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|