Device Classification Name |
subsystem, water purification
|
510(k) Number |
K873487 |
Device Name |
HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES |
Applicant |
WATER PURE, INC. |
11003 BLUEGRASS PKWY. |
SUITE 600, BLDG. A |
LOUISVILLE,
KY
40299
|
|
Applicant Contact |
RONALD L WATHEN |
Correspondent |
WATER PURE, INC. |
11003 BLUEGRASS PKWY. |
SUITE 600, BLDG. A |
LOUISVILLE,
KY
40299
|
|
Correspondent Contact |
RONALD L WATHEN |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 08/31/1987 |
Decision Date | 10/23/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|