Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K972731 |
Device Name |
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET |
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 | 876.5630
|
Classification Product Code |
|
Date Received | 07/22/1997 |
Decision Date | 09/29/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|