Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K014169 |
Device Name |
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS |
Applicant |
BOB J. JOHNSON & ASSOC., INC |
7715 MAINLAND DR. # 115 |
SAN ANTONIO,,
TX
78250
|
|
Applicant Contact |
ROBERT SNYDER |
Correspondent |
BOB J. JOHNSON & ASSOC., INC |
7715 MAINLAND DR. # 115 |
SAN ANTONIO,,
TX
78250
|
|
Correspondent Contact |
ROBERT SNYDER |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 12/19/2001 |
Decision Date | 02/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|