Device Classification Name |
system, peritoneal, automatic delivery
|
510(k) Number |
K823827 |
Device Name |
AMP 80/2 OUTFLOW MONITOR MODIFICATION |
Applicant |
AMERICAN MEDICAL PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
AMERICAN MEDICAL PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 12/20/1982 |
Decision Date | 03/17/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|