Device Classification Name |
dialysate concentrate for hemodialysis (liquid or powder)
|
510(k) Number |
K993212 |
Device Name |
DRYASOL ACID CONCENTRATE MIX |
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 | 09/24/1999 |
Decision Date | 10/22/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|