Device Classification Name |
System, Peritoneal, Automatic Delivery
|
510(k) Number |
K822543 |
Device Name |
CAPD SAFE LOCK TRANSFER SET |
Applicant |
AMERICAN MEDICAL PRODUCTS, INC. |
P.O. DRAWER 190 |
FREEHOLD,
NJ
07728
|
|
Applicant Contact |
JOSEPH J BUTLER |
Correspondent |
AMERICAN MEDICAL PRODUCTS, INC. |
P.O. DRAWER 190 |
FREEHOLD,
NJ
07728
|
|
Correspondent Contact |
JOSEPH J BUTLER |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 08/23/1982 |
Decision Date | 10/13/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|