Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K020230 |
Device Name |
DIASOL-BICARB |
Applicant |
DIASOL, INC. |
13212 RAYMER ST. |
NORTH HOLLYWOOD,
CA
91605
|
|
Applicant Contact |
MONICA ABELES |
Correspondent |
DIASOL, INC. |
13212 RAYMER ST. |
NORTH HOLLYWOOD,
CA
91605
|
|
Correspondent Contact |
MONICA ABELES |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 01/23/2002 |
Decision Date | 04/23/2002 |
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
|
|
|