Device Classification Name |
system, peritoneal, automatic delivery
|
510(k) Number |
K833065 |
Device Name |
AUTOMATIC PERITONEAL DIALYSIS CYCLER |
Applicant |
TRAVENOL LABORATORIES, S.A. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
TRAVENOL LABORATORIES, S.A. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 09/08/1983 |
Decision Date | 11/28/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|