Device Classification Name |
subsystem, proportioning
|
510(k) Number |
K810605 |
Device Name |
CHEMATIC BICARBONATE DIALYSATE SYSTEM |
Applicant |
TRIMEDYNE, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
TRIMEDYNE, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/06/1981 |
Decision Date | 06/16/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|