Device Classification Name |
Subsystem, Proportioning
|
510(k) Number |
K800772 |
Device Name |
MOD. DM-357 BICARBONATE RETROFIT KIT |
Applicant |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/07/1980 |
Decision Date | 05/14/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|