Device Classification Name |
subsystem, water purification
|
510(k) Number |
K000249 |
Device Name |
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 |
Applicant |
SCHAEFER WATER CENTERS |
HIGHWAY 61-67 |
1555 COMERCIAL BLVD |
HERCULANEUM,
MO
63048
|
|
Applicant Contact |
MICHAEL J SCHAEFER |
Correspondent |
SCHAEFER WATER CENTERS |
HIGHWAY 61-67 |
1555 COMERCIAL BLVD |
HERCULANEUM,
MO
63048
|
|
Correspondent Contact |
MICHAEL J SCHAEFER |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 01/27/2000 |
Decision Date | 12/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|