Device Classification Name |
System, Dialysate Delivery, Central Multiple Patient
|
510(k) Number |
K844734 |
Device Name |
ALCIDE REN NEW-D |
Applicant |
ALCIDE CORP. |
125 MAIN ST. |
WESTPORT,
CT
06880
|
|
Applicant Contact |
HARRY M KAUFMAN |
Correspondent |
ALCIDE CORP. |
125 MAIN ST. |
WESTPORT,
CT
06880
|
|
Correspondent Contact |
HARRY M KAUFMAN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 12/04/1984 |
Decision Date | 05/17/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|