Device Classification Name |
subsystem, water purification
|
510(k) Number |
K983239 |
Device Name |
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS |
Applicant |
RASCO |
1635-2 WOODSIDE DR. |
WOODBRIDGE,
VA
22191
|
|
Applicant Contact |
VINCENT J CICCONE |
Correspondent |
RASCO |
1635-2 WOODSIDE DR. |
WOODBRIDGE,
VA
22191
|
|
Correspondent Contact |
VINCENT J CICCONE |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 09/15/1998 |
Decision Date | 11/18/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|