Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K863720 |
Device Name |
HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES |
Applicant |
WATER PURE, INC. |
507 BRANDON RD. |
LOUISVILLE,
KY
40207
|
|
Applicant Contact |
WATHEN, M.D. |
Correspondent |
WATER PURE, INC. |
507 BRANDON RD. |
LOUISVILLE,
KY
40207
|
|
Correspondent Contact |
WATHEN, M.D. |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 09/23/1986 |
Decision Date | 10/29/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|